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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
Jul 11, 2017 Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analy... Instruments may, under certain specific circumstances listed below, fail to stop when a test is i... Class II Olympus Scientific Solutions Americas
Jan 7, 2017 Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyz... It was discovered under rare circumstances the LED warning light circuit could fail. If this happ... Class II Olympus Scientific Solutions Americas
Oct 27, 2016 Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analy... Possible unintentional x-ray emission after users attempt early termination of the sequence. Class II Olympus Scientific Solutions Americas
Jun 22, 2016 Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical ... Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in tes... Class II Olympus Scientific Solutions Americas
Jan 13, 2016 Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer... The Firm has discovered a Software bug. Class II Olympus Scientific Solutions Americas
Jun 9, 2015 Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta... Higher than published scatter around the probe head when testing some samples. At the point the c... Class II Olympus Scientific Solutions Americas

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.