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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Oct 27, 2014 Drill set long, drill stop compatible for 4.8mm diameter implant, Article Num... Drill set may contain incorrect drill. Class II Straumann USA, LLC
Sep 24, 2014 Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Arti... Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) Class II Straumann USA, LLC
Sep 19, 2014 Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Lox... Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) Class II Straumann USA, LLC
Jul 11, 2012 Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dent... Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for... Class II Straumann USA, LLC

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.