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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Dec 18, 2025 Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a... Potential for fraying on the body support strap. Class II Community Products, LLC
Dec 18, 2025 Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a g... Potential for fraying on the body support strap. Class II Community Products, LLC
Dec 18, 2025 Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered ... Potential for fraying on the body support strap. Class II Community Products, LLC
Mar 21, 2019 Rifton E-Pacer, SKU K660, powered lift device A design change to the load-bearing quick release buckle renders the springs in the latch mechani... Class II Community Products, LLC
Mar 21, 2019 Rifton TRAM Low Base, SKU K320, powered lift device A design change to the load-bearing quick release buckle renders the springs in the latch mechani... Class II Community Products, LLC
Mar 21, 2019 Rifton TRAM Standard Base, SKU K310, powered lift device A design change to the load-bearing quick release buckle renders the springs in the latch mechani... Class II Community Products, 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.