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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Aug 24, 2016 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacter... Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the... Class I Baxter Corporation Englewood
Dec 21, 2015 Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syr... All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month sh... Class II Baxter Corporation Englewood
Apr 8, 2015 ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Editi... Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possib... Class II Baxter Corporation Englewood
Dec 29, 2014 Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Cap... Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both sin... Class II Baxter Corporation Englewood
Dec 4, 2014 Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Y... Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because the... Class II Baxter Corporation Englewood
May 28, 2014 Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculati... Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1,... Class II Baxter Corporation Englewood
Apr 16, 2014 RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF... Possible breach in sterile barrier for inner and outer bags of the product. Class II Baxter Corporation Englewood
Apr 2, 2014 ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculat... 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values durin... Class I Baxter Corporation Englewood
Dec 3, 2013 ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Editio... Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutri... Class II Baxter Corporation Englewood

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.