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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 in 2005.

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DateProductReasonClassFirm
Dec 27, 2005 Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as sin... The system has a gap that can appear between the upper and lower tilt stand covers. The fingers m... Class II Philips Medical Systems (Cleveland) Inc
Jul 8, 2005 SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The d... The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product lin... Class II JK Products & Services, Inc
Jul 1, 2005 Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) heari... Siemens became aware of an issue where an infant or child could open the tamper resistant battery... Class II Siemens Hearing Instruments, 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.