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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Apr 25, 2023 SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample c... Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to b... Class II LumiraDx
Sep 23, 2022 LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L0160... Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers wer... Class III LumiraDx
Jun 24, 2022 LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the... Class II LumiraDx
Jun 24, 2022 LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the... Class II LumiraDx
Feb 3, 2021 Coronavirus antigen detection test system - Product Usage: intended for the q... Two lots of test strips failed QC testing using blank buffer due to false positives. Class II LumiraDx
Jan 11, 2021 LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Sever... Observations of potential false positive results in the specified lots. Use of these test strips ... Class II LumiraDx

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.