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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.

Clear
DateProductReasonClassFirm
Jun 14, 2018 RT-5100 Refractor, a component of the Epic-5100 System. The lens bonding was incomplete on the refractor. Class III Nidek Inc.
Dec 20, 2017 AUTO REF/KERATOMETER ARK-1s There is possibly a difference between the measured dioptric value of the subjective measurement ... Class II Nidek Inc.
Jul 1, 2016 OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: ... Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial leng... Class II Nidek Inc
Jun 9, 2014 MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufact... Laser aperture label was not affixed to device prior to shipment in the US. Class II Nidek 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.