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Browse Device Recalls

111 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 111 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 111 FDA device recalls.

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DateProductReasonClassFirm
Aug 15, 2013 Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Me... Dr¿ger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained... Class II Steris Corporation
May 20, 2013 STERIS Fine Traction Device, one unit per box Product Usage: The Fine Tra... A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-re... Class II Steris Corporation
Mar 4, 2013 Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, ... During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be upd... Class II Steris Corporation
Feb 12, 2013 AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat an... The control boards alarm set points and temperature tolerances allowed for erroneous activation ... Class II Steris Corporation
Aug 10, 2012 QKC1692E The QKC1692E Quick Connect device connects endoscopes to the ste... STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was una... Class II Steris Corporation
Aug 2, 2012 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into... On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it ... Class III Steris Corporation
Aug 1, 2012 The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Ste... The firm initiated a recall after complaint investigations revealed that when the units are left ... Class II Steris Corporation
Jul 14, 2012 The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanic... To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close ... Class II Steris Corporation
Jul 3, 2012 Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 932... STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specificat... Class II Steris Corporation
Apr 6, 2012 STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a... STERIS has learned from Customer feedback and field service experience that damage from external ... Class II Steris Corporation
Feb 17, 2010 A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible gener... Customers may be storing objects on the base and/or around the column of the surgical table. Thi... Class II Steris Corporation

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.