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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 7 FDA device recalls.

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DateProductReasonClassFirm
May 26, 2021 Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with bui... Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed con... Class II Owen Mumford USA, Inc.
Jul 17, 2019 Petfine Auto Injector, REF 3310VET There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two ... Class II Owen Mumford USA, Inc.
Jul 17, 2019 Autoject EI, REF AJ1310 There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two ... Class II Owen Mumford USA, Inc.
Nov 6, 2017 Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Pro... Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp... Class II Owen Mumford USA, Inc.
Nov 6, 2017 Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Pro... Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp... Class II Owen Mumford USA, Inc.
Dec 11, 2014 Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN... The dials in the Autopens are not working - the dial does not stay dialed, but springs right back... Class II Owen Mumford USA, Inc.
Nov 24, 2014 Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 ... The syringe carrier is missing components: a damper and spring. Class II Owen Mumford USA, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.