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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
Jul 30, 2020 AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in v... Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol... Class II RANDOX LABORATORIES, LTD.
Jul 30, 2020 AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in v... Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol... Class II RANDOX LABORATORIES, LTD.
Jul 10, 2020 Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked... Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the qu... Class II RANDOX LABORATORIES, LTD.
Jul 10, 2020 Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the qu... Class II RANDOX LABORATORIES, LTD.
Jun 26, 2020 Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase te... Randox have confirmed imprecision of quality control and patient samples when using specific Rand... Class II RANDOX LABORATORIES, LTD.
Jun 26, 2020 Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase ... Randox have confirmed imprecision of quality control and patient samples when using specific Rand... Class II RANDOX LABORATORIES, LTD.
Jun 26, 2020 Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipa... Randox have confirmed imprecision of quality control and patient samples when using specific Rand... Class II RANDOX LABORATORIES, LTD.

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.