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Lower risk Medical device recall · FDA · Published January 4, 2021

Olympus INJECTOR FORCEMAX 25G 2.5MM Recall: Risk of infection from poor seal

Olympus recalls INJECTOR FORCEMAX 25G 2.5MM (model NM-400U-0425) due to potential inadequate sterile packaging seals. Patients could develop infections if non-sterile equipment is used. Affected units were sold in specific batches.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1018-2021Medical deviceOlympus ›
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Recalling firmAomori Olympus Co., Ltd.2 Chome 248-1, Okkonoki · Kuroishi, Japan
✎ GovInfoNow plain-language explainer

Olympus is recalling a specific type of endoscopic injection device because some sterile packages have poor seals. This could lead to infections if the device is used without proper sterility. Read more at govinfonow.com/recall/63470-olympus-injector-forcemax-25g-2-5mm-recall-risk-of-infection.

Source Summary by GovInfoNow · govinfonow.com/recall/63470-olympus-injector-forcemax-25g-2-5mm-recall-risk-of-infection · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1018-2021

Cite this page

“Olympus INJECTOR FORCEMAX 25G 2.5MM Recall: Risk of infection from poor seal.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63470-olympus-injector-forcemax-25g-2-5mm-recall-risk-of-infection. Based on FDA recall #Z-1018-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1018-2021%22&limit=1).

The FDA announced on Jan. 4, 2021, that Aomori Olympus Co., Ltd. recalled the Olympus INJECTOR FORCEMAX 25G 2.5MM due to inadequate package seals that may lead to patient infections. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Olympus
  • Product: INJECTOR FORCEMAX 25G 2.5MM
  • Model no.: NM-400U-0425
  • Lot codes: 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV
  • Distribution: US Nationwide

The hazard

FDA inspection confirmed a small percentage of sterile packages had inadequate package seals, specifically partial heat seals. Patients may develop infections if non-sterile equipment is used.

Context

GovInfoNow's records show Aomori Olympus Co., Ltd. has one other recall on record since July 27, 2023, involving DEHP chemical risk in disposable EMR kits. Other recent recalls of similar products include the Olympus Single Use Biopsy Valve Recall (Jan. 29, 2026) and the Olympus Single Use Sphincterotome V Recall (Jan. 7, 2026). The Medline Forceps Recall occurred on Nov. 13, 2025.

How to tell if you have this one

Check for the model number NM-400U-0425 on the device. Affected units were sold in specific batches labeled 01K through 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V through 09V, 0XV.

  • Brand
    Olympus
  • Category
    Medical device
FDA recall event · 111 products

All 111 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-0961-2021B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.; 01K, 03K, 04K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0962-2021B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0963-2021B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0964-2021B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.; 01K, 02K, 03K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0965-2021B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.; 01K, 02K, 03K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0966-2021B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.; 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (global); 260,395 (US)
Z-0967-2021B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.; 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (global); 260,395 (US)
Z-0968-2021B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.; 06V, 07V, 08V, 09V, 0XV7,400,000 (global); 260,395 (US)
Z-0969-2021PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0970-2021K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0971-2021K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0972-2021K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0973-2021K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K,02K,03K,04K,05K,06K,07K,08K,09K,95K,96K,97K,98K,99K,9XK,9YK,9ZK7,400,000 (global); 260,395 (US)
Z-0974-2021KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0975-2021KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0976-2021KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0977-2021KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0978-2021KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0979-2021KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0980-2021KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0981-2021KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0982-2021KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.; 01K, 02K, 03K, 04K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0983-2021KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (global); 260,395 (US)
Z-0984-2021SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.; 01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, 9YV7,400,000 (global); 260,395 (US)
Z-0985-2021SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.; 05K, 07K, 09K, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, 9YV7,400,000 (global); 260,395 (US)
Z-0986-2021SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.; 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V7,400,000 (globally); 260,395 (US)
Z-0987-2021SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.; 97V, 98V, 9XV, 9YV, 03V, 04V, 05V, 06V, 07V7,400,000 (globally); 260,395 (US)
Z-0988-2021SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.; 97V, 99V, 9XV, 9YV, 03V, 04V, 05V, 06V, 07V7,400,000 (globally); 260,395 (US)
Z-0989-2021SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.; 97V, 98V, 99V, 9YV, 03V, 04V, 05V, 06V, 07V7,400,000 (globally); 260,395 (US)
Z-0990-2021SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.; 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V7,400,000 (globally); 260,395 (US)
Z-0991-2021SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.; 97V, 98V, 9XV, 9YV, 03V, 05V, 06V7,400,000 (globally); 260,395 (US)
Z-0992-2021SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.; 97V, 98V, 03V, 04V, 06V7,400,000 (globally); 260,395 (US)
Z-0993-2021INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-0994-2021INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-0995-2021INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-0996-2021INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-0997-2021INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 04K, 05K, 07K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-0998-2021INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-0999-2021INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 05K, 07K, 08K, 09K, 99K, 9XK, 9YK, 9ZK,7,400,000 (globally); 260,395 (US)
Z-1000-2021INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 04K, 05K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1001-2021INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1002-2021INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1003-2021INJECTOR FORCEMAX LOWER 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1004-2021INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1005-2021INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1006-2021INJECTOR FORCEMAX LOWER 23G 6MM, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1007-2021INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1008-2021INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, O5V, 06V, O7V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1009-2021INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 03K, 04K, 05K, 06K, 98K, 99K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1010-2021INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1011-2021INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1012-2021INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1013-2021INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1014-2021INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 04K, 05K, 07K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1015-2021INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K ,04K, 05K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1016-2021INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1017-2021INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1018-2021INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1019-2021INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1020-2021INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K,06K, 07K,08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1021-2021INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 05K, 06K, 09K, 0XK, 98K, 99K, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1022-2021INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 05K, 06K, 09K, 98K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1023-2021INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 03K, 04K, 05K, 07K, 0XK, 98K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1024-2021INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1025-2021INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1026-2021INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1027-2021INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1028-2021INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 02K, 03K, 04K, 06K, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1029-2021INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.; 01K, 02K, 04K, 05K, 06K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1030-2021NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 03K, 04K, 08K, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1031-2021NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1032-2021NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 02K, 03K, 05K, 07K, 08K, 0XK, 98K, 99K, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1033-2021NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1034-2021NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 05K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1035-2021NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 98K, 99K, 9YX, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1036-2021NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 03K, 04K, 05K, 0XK, 98K, 99K, 9XK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1037-2021NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 02K, 09K, 99K, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1038-2021NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 9XK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1039-2021NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1040-2021NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1041-2021NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 04K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1042-2021NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1043-2021NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1044-2021NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1045-2021NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 03K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1046-2021NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 03K, 04K, 05K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1047-2021NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1048-2021NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 04K, 06K, 0XK, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1049-2021NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1050-2021K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1051-2021K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1052-2021K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1053-2021K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1054-2021NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1055-2021NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1056-2021NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1057-2021NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1058-2021NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1059-2021NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK, 95V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V,09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1060-2021NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.; 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1061-2021NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.; 07K, 08K, 92K, 93K, 95V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1062-2021NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.; 03K, 04K, 95V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV7,400,000 (globally); 260,395 (US)
Z-1063-2021PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.; 97K7,400,000 (globally); 260,395 (US)
Z-1064-2021PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.; 04K7,400,000 (globally); 260,395 (US)
Z-1065-2021PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.; 95K, 96K, 97K, 98K, 99K7,400,000 (globally); 260,395 (US)
Z-1066-2021PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.; 01K, 02K7,400,000 (globally); 260,395 (US)
Z-1067-2021MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.; 01K, 02K, 04K, 05K, 06K, 07K, 09K, 92K, 93K, 94K, 95K, 97K, 9XK7,400,000 (globally); 260,395 (US)
Z-1068-2021MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.; 01K, 02K, 03K, 92K, 93K, 94K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1069-2021NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.; 01K, 02K, 03K, 04K, 05K, 06K, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1070-2021CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.; 01K, 02K, 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Z-1071-2021CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.; 01K, 02K, 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK7,400,000 (globally); 260,395 (US)
Based on the official FDA remedy

What to do — step by step

  1. Check Device Seal

    Inspect the packaging for signs of a poor seal, though the recall does not specify visual indicators.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

1. Firm started the recall: Jan 4, 202112. FDA classified it Class II: Feb 5, 202123. Published in FDA’s Enforcement Report: Feb 17, 202134. FDA terminated the recall: Mar 11, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1018-2021 (January 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1018-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA