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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
Apr 12, 2016 Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-03... Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem w... Class II Toshiba American Medical Systems Inc
Oct 15, 2014 AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS M... During routine periodic packaging testing, AMS identified that in simulated extreme shipping and ... Class II American Medical Systems, Inc.
Oct 15, 2014 AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF... During routine periodic packaging testing, AMS identified that in simulated extreme shipping and ... Class II American Medical Systems, Inc.
Oct 10, 2014 AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Acces... AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS... Class II American Medical Systems, Inc.
Mar 1, 2013 AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is u... American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary C... Class II American Medical Systems, Inc.
Mar 1, 2013 AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is ... American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary C... Class II American Medical Systems, Inc.
Oct 19, 2012 AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US)... American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿... Class II American Medical Systems, 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.