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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Jun 28, 2017 GE Inspection Technologies Blade|line Industrial Cabinet X-ray system GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to compl... Class II GE Inspection Technologies, LP
Mar 2, 2016 GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems.... Radiation emissions which exceeded the limit in the performance standard were detected during mai... Class II GE Inspection Technologies, LP
Dec 16, 2015 GE Inspection Technologies, LP, Cabinet X-ray system used for industrial qual... GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems ma... Class II GE Inspection Technologies, LP
Jan 13, 2015 GE Inspection Technologies x|argos 160D system. Cabinet x-ray system. It was discovered that the upper left corner-shaped lead shield in the window in one of the doors... Class II GE Inspection Technologies, LP
Jan 13, 2015 GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system It was discovered that the upper left corner-shaped lead shield in the window in one of the doors... Class II GE Inspection Technologies, LP
Nov 10, 2014 GE Cabinet X-ray systems GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray Sys... Class II GE Inspection Technologies, LP
Nov 10, 2014 GE Optional Laser Centering Device X-ray generator. GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 f... Class II GE Inspection Technologies, LP

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.