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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
Oct 8, 2025 Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CAT... Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... Class II Sterilmed, Inc.
Oct 8, 2025 Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WIT... Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... Class II Sterilmed, Inc.
Sep 17, 2018 Reprocessed Agilis Steerable Introducer: indicated for introducing various c... Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specific... Class II Sterilmed, Inc.
Apr 26, 2016 Reprocessed Microline Scissor Tips intended to be used with a reusable hand p... Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect th... Class II STERILMED, INC.
Nov 13, 2015 Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Steril... Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed ca... Class II STERILMED, INC.
Aug 24, 2015 Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Br... Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot nu... Class II STERILMED, INC.
Sep 24, 2014 Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters... Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an ... Class II STERILMED, 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.