Lower risk Medical device recall · FDA · Published November 19, 2018

Smiths Medical Medex High Pressure Stopcock Leak Recall: Fix Leaks Before Using

Smiths Medical recalls Medex High Pressure Stopcocks with potential leaks. These single-use IV devices may leak if defective. Check model numbers and lot numbers listed to see if your item is affected.

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

🇺🇸 FDA recall #Z-0512-2019Medical device Smiths Medical ›

Lower-risk recall

Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924

Take action

Contact the company

Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690

✎ GovInfoNow plain-language explainer

Smiths Medical is recalling Medex High Pressure Stopcocks that may leak due to a manufacturing defect. This could cause IV fluid to leak, potentially leading to infection or other complications if the device is used. Read more at govinfonow.com/recall/69454-smiths-medical-medex-high-pressure-stopcock-leak-recall-fix-leaks.

Source Summary by GovInfoNow · govinfonow.com/recall/69454-smiths-medical-medex-high-pressure-stopcock-leak-recall-fix-leaks · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0512-2019

Cite this page

“Smiths Medical Medex High Pressure Stopcock Leak Recall: Fix Leaks Before Using.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69454-smiths-medical-medex-high-pressure-stopcock-leak-recall-fix-leaks. Based on FDA recall #Z-0512-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0512-2019%22&limit=1).

The FDA announced on 2018-11-19 that Smiths Medical ASD Inc. is recalling certain Medex High Pressure Stopcocks due to a manufacturing defect that may cause leaks. The agency issued recall number Z-0512-2019 for the Class II device.

How to tell if you have it

Brand: Smiths Medical
Product: Medex High Pressure Stopcock
Model MX4301L, Lot 3538569
Model MX4331L, Lots 3562377 and 3546826
Model MX4331R, Lot 3546924
Quantity: 2,425 devices
Distribution: Shipped to customers in the US, Canada, and Mexico

The hazard

According to the FDA, certain lots of Medex High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. The device is intended for single use only.

Context

GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since 2017-06-05. Recent Smiths Medical recalls include the 2025-04-10 CADD Solis VIP Infusion Pump Recall for potential thermal damage and the 2025-04-10 CADD-Solis HPCA Infusion Pump Recall for false alarm risks. Other recent recalls of similar products include Medline Convenience Kits with Swan-Ganz Catheters Recalled Due to Leak Risk (2026-05-28), Medline IV Sets May Leak Chemicals and Break, Risking Patient Harm (2025-12-31), and Medline IV Kits Recall: Check Valve Stuck in Open or Closed Position (2025-11-26).

How to tell if you have this one

Check the model number and lot number on the stopcock. Affected items have model numbers MX4301L (lot 3538569), MX4331L (lots 3562377 and 3546826), or MX4331R (lot 3546924).

Brand
Smiths Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model and Lot Numbers
Look for the model number and lot number on the stopcock to see if it matches the affected items listed.

How this recall unfolded

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Nov 19, 2018Firm started the recall
Nov 28, 2018FDA classified it Class II
Dec 5, 2018Published in FDA’s Enforcement Report
Jun 5, 2020FDA terminated the recall

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

Similar recalls

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/69454-smiths-medical-medex-high-pressure-stopcock-leak-recall-fix-leaks">Smiths Medical Medex High Pressure Stopcock Leak Recall: Fix Leaks Before Using (GovInfoNow)</a>

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-0512-2019 (November 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0512-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.