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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
May 19, 2022 MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of th... Class II Chromsystems Instruments & Chemicals GmbH
May 19, 2022 MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of th... Class II Chromsystems Instruments & Chemicals GmbH
Nov 2, 2020 MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Produ... XXX Class II Chromsystems Instruments & Chemicals GmbH
Nov 2, 2020 MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Prod... XXX Class II Chromsystems Instruments & Chemicals GmbH
Nov 2, 2020 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The... Products do not meet stability criteria and may impact results. Class II Chromsystems Instruments & Chemicals GmbH
Nov 2, 2020 MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Produc... Products do not meet stability criteria and may impact results. Class II Chromsystems Instruments & Chemicals GmbH
Oct 29, 2020 MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Produc... Control lots may not meet stability criteria and could result in increased results of patient sam... Class II Chromsystems Instruments & Chemicals GmbH
Oct 29, 2020 MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Produ... Control lots may not meet stability criteria and could result in increased results of patient sam... Class II Chromsystems Instruments & Chemicals GmbH
Oct 29, 2020 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order N... Calibrator lots may not meet stability criteria and could result in increased results of patient ... Class II Chromsystems Instruments & Chemicals GmbH

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.