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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Jan 3, 2017 Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usag... During use, there is a potential scenario which could allow the fastening screws attaching covers... Class II Allen Medical Systems, Inc.
Nov 23, 2016 Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and d... During use, the unit could separate un-expectantly. This failure would allow the patient's arm t... Class II Allen Medical Systems, Inc.
Feb 28, 2013 Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fractur... Some units may have been assembled incorrectly which could result in the boot breaking free from ... Class II Allen 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.