Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published April 22, 2023

Merit Medical Aspira Pleural Drainage Tray: Valve may not open, preventing fluid drainage

Merit Medical recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F (REF: 499:2509) due to potential valve failure preventing fluid drainage. Affected units have specific lot numbers and UDI-DI codes.

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

🇺🇸 FDA recall #Z-1915-2023Medical deviceMerit Medical Systems ›
Take action

Contact the company

Recalling firmMerit Medical Systems, Inc.1600 W Merit Pkwy · South Jordan, UT 84095-2416
✎ GovInfoNow plain-language explainer

What happened, in plain English

Merit Medical is recalling Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies might not open, which could prevent fluid drainage. This is a medical device used during pleural drainage procedures and could lead to complications if fluid builds up. Read more at govinfonow.com/recall/58518-merit-medical-aspira-pleural-drainage-tray-valve-may-not-open.

Source Summary by GovInfoNow · govinfonow.com/recall/58518-merit-medical-aspira-pleural-drainage-tray-valve-may-not-open · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1915-2023

Cite this page

“Merit Medical Aspira Pleural Drainage Tray: Valve may not open, preventing fluid drainage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58518-merit-medical-aspira-pleural-drainage-tray-valve-may-not-open. Based on FDA recall #Z-1915-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1915-2023%22&limit=1).

Why it’s dangerous

The valve assemblies in the tray may not open properly, which could prevent fluid from draining from the pleural space. This might cause fluid buildup and potential complications during medical procedures.

Who’s affected

Healthcare professionals using the Aspira Pleural Drainage Catheter Insertion Tray for pleural drainage procedures are most at risk. Patients receiving this device during medical treatment may also be affected.

How to tell if you have this one

Check for the product name 'Aspira Pleural Drainage Catheter Insertion Tray 15.5F', reference number 4992509, version A, and sterile EO packaging. Lot numbers include I2614171, I2559314, I2546596, I2614170, I2538442, I2564679, I2548181, I2623231.

  • Brand
    Merit Medical Systems
  • Category
    Medical device
FDA recall event · 13 products

All 13 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
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.
Recall numberProduct, codes & lotsQuantity
Z-1908-2023Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only; Lot # I2605742; UDI-DI: 008844503981665 units
Z-1909-2023Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only; Lot # I2605742; UDI-DI: 0088445039816627 units
Z-1910-2023Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only; Lot # I2538438, I2614180, I2623234/ UDI: 00884450394892175 units
Z-1911-2023Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only; Lot # I2533611, I2546597, I2559292, I2548163 & I2578001; UDI-DI: 00884450394908670 units
Z-1912-2023Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only; Lot # I2632727, I2558682, I2623159, I2618461 ; UDI-DI: 00884450398173156 units
Z-1913-2023Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only; Lot # I2548172, I2568218, I2553914, I2614174, I2638785, I2559299; UDI-DI: 00884450394915524 units
Z-1914-2023Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only; Lot # I2559297, I2564678, I2553915, I2614173, I2568219; UDI-DI: 00884450394939436 units
Z-1915-2023Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only; Lot # I2614171, I2559314, I2546596, I2614170, I2538442, I2564679, I2548181, I2623231; UDI-DI: 008844503949461054 units
Z-1916-2023Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only; Lot # I2604364, I2604393, I2587036, I2564649, I2558681, I2604394, I2609065, I2623156, I2577984; UDI-DI: 008844503949602559 units
Z-1917-2023Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only; Lot # I2587050; UDI-DI: 0088445048844717 units
Z-1918-2023Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only; Lot # I2578012; UDI-DI: 008844504885397 units
Z-1919-2023Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only; Lot # I2587055; UDI-DI: 0088445048841640 units
Z-1920-2023Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only; Lot # I2559306; UDI-DI: 008844504884922 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product name, reference number, version, and lot numbers to confirm if your tray is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 47 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Apr 22, 202312. FDA classified it Class II: Jun 14, 202323. Published in FDA’s Enforcement Report: Jun 21, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

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-1915-2023 (April 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1915-2023 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