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Browse Device Recalls

21 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 21 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 21 FDA device recalls.

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DateProductReasonClassFirm
Nov 4, 2022 Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter i... XXX Class II Medical Action Industries, Inc. 306
Oct 12, 2022 Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, ... Scissors contained debris. Class II Medical Action Industries, Inc. 306
Oct 12, 2022 Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), ... The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label ... Class II Medical Action Industries, Inc. 306
May 11, 2021 Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat,... There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... Class II Medical Action Industries, Inc. 306
May 11, 2021 Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209 There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... Class II Medical Action Industries, Inc. 306
May 11, 2021 Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, R... There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... Class II Medical Action Industries, Inc. 306
May 11, 2021 Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214 There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... Class II Medical Action Industries, Inc. 306
Mar 1, 2019 Laparotomy Sponge with the following product description and model numbers: ... Potential lack of sterility assurance Class II Medical Action Industries Inc
Nov 27, 2018 Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed wi... Potential compromise of product sterility due to breach of sterile barrier. Class II Medical Action Industries Inc
Dec 11, 2017 Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels p... Product sterility potentially compromised. Class II Medical Action Industries Inc
Apr 19, 2017 Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Tow... Lint present on sterile Operating Room Towels. Class II Medical Action Industries Inc
Apr 19, 2017 White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Inte... Lint present on sterile Operating Room Towels. Class II Medical Action Industries Inc
Feb 3, 2016 PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single U... Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit,... Class II Medical Action Industries Inc
Jun 12, 2014 McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single ... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Us... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical A... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Ind... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical A... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Indu... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Actio... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries Inc
Jun 12, 2014 Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20... Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class II Medical Action Industries 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.