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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

Clear
DateProductReasonClassFirm
Aug 17, 2020 Speed Stitch Needle Cassette Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result,... Class II ArthroCare Corporation
Feb 21, 2019 Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE ... The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper... Class II ArthroCare Corporation
Mar 3, 2016 TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ... During functional testing of devices after real time aging, it was determined that product failed... Class II ArthroCare Corporation
Oct 26, 2015 Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation ... There is cracking in the tray when the device is snapped into place. The crack is through the ful... Class II ArthroCare Corporation
Jun 2, 2015 EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable ... Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (H... Class II ArthroCare 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.