Skip to content
Get alerts
GovInfoNow
Use caution Medical device recall · FDA · Published November 10, 2023

Smiths Medical 48IN Inject Line Rotating Adapt Recall: Medication Leak Risk

Smiths Medical recalls 48-inch inject line rotating adapters with potential medication leaks due to O-ring seal defects. Affected units have specific lot numbers; stop using if you have the product.

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

🇺🇸 FDA recall #Z-0747-2024Medical deviceSmiths Medical ›
Take action

Contact the company

Recalling firmSmiths Medical Asd Inc6250 Shier Rings Rd · Dublin, OH 43016-1270
✎ GovInfoNow plain-language explainer

Smiths Medical is recalling certain 48-inch inject line rotating adapters because a manufacturing defect may cause medication leaks during use. This could lead to under-infusion of medication, which is a serious risk for patients. Read more at govinfonow.com/recall/56880-smiths-medical-48in-inject-line-rotating-adapt-recall-medication-leak.

Source Summary by GovInfoNow · govinfonow.com/recall/56880-smiths-medical-48in-inject-line-rotating-adapt-recall-medication-leak · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0747-2024

Cite this page

“Smiths Medical 48IN Inject Line Rotating Adapt Recall: Medication Leak Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56880-smiths-medical-48in-inject-line-rotating-adapt-recall-medication-leak. Based on FDA recall #Z-0747-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0747-2024%22&limit=1).

Smiths Medical ASD, Inc. recalled 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi) infusion lines due to a manufacturing defect that may cause medication leaks and under-infusion, the FDA said on Nov. 10, 2023.

How to tell if you have it

  • Brand: Smiths Medical
  • Product: 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi)
  • List Number: MX694R
  • Lot Numbers: 4383431, 4387987, 4404698

The hazard

The FDA reported a manufacturing defect affecting specific rotator lots where the inner diameter of the device's O-ring may be oversized. This defect affects seal integrity and may lead to a leak during infusion of medication, which may potentially lead to under-infusion of medication.

Context

GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since June 5, 2017. Other recent recalls of similar products include Medline medical convenience kits recall (Feb. 27, 2026), B Braun Medical Outlook IV Set Recall (Oct. 29, 2025), and Medline Medical Kits Recall (Feb. 27, 2026).

How to tell if you have this one

Check for the product name '48IN (121.9CM) INJ LINE ROTATING ADAPT (9:00psi)' with lot numbers 4383431, 4387987, or 4404698. The product was sold with list number MX694R.

  • Brand
    Smiths Medical
  • Category
    Medical device
FDA recall event · 9 products

All 9 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 distribution - US Nationwide and the countries of Canada, UAE.
Recall numberProduct, codes & lots
Z-0739-2024Medex LOGICAL CATH LAB KIT, List Number M20754; UDI-DI: 10351688510686; Lot Number: 4371054
Z-0740-20241050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL; Lot Number: 4387166
Z-0741-20246IN PRESSURE TUBING, List Number MX20617; Lot Number: 4380614, 4416451
Z-0742-2024Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R; Lot Number: 4355397 4380735 4387234 4404740
Z-0743-2024HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP; Lot Number: 4332915 4408772
Z-0744-2024HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP; Lot Number: 4330826 4384397
Z-0745-202420IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR; Lot Number: 4398428 4404690
Z-0746-2024Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R; Lot Number: 4398433
Z-0747-202448IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R; Lot Number: 4383431 4387987 4404698
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the lot number on your adapter to see if it matches 4383431, 4387987, or 4404698.

  2. Stop Using if Recalled

    If your adapter has a recalled lot number, stop using it immediately to prevent medication leaks.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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: “Worldwide distribution - US Nationwide and the countries of Canada, UAE.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

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

1. Firm started the recall: Nov 10, 202312. FDA classified it Class II: Jan 17, 202423. Published in FDA’s Enforcement Report: Jan 24, 2024320232024
  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.

Other Smiths Medical recalls

Smiths Medical ASD Inc. recalls paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
May 31, 2024Smiths Medical ASD Inc. recalls Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
May 31, 2024Smiths Medical ASD Inc. recalls smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
February 7, 2024

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, 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-0747-2024 (November 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0747-2024 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