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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.

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DateProductReasonClassFirm
Jul 14, 2017 PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3 The lift motor used to raise and lower the overhead chassis will wear if not properly maintained ... Class II Panoramic Rental Corp.
Aug 19, 2016 Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage:... Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ra... Class II Panoramic Rental Corp.
Jun 4, 2015 Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take pan... Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury. Class II Panoramic Rental Corp.

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.