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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
Nov 7, 2022 R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, ... For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration... Class III R & D Systems, Inc.
Jun 14, 2022 Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative co... The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm co... Class III R & D Systems, Inc.
Jan 20, 2021 Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR imm... R&D Systems, Inc. received two complaints that the standard signal was low and controls were not ... Class II R & D Systems, Inc.
Nov 1, 2018 Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The Qu... The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorre... Class III R & D Systems, Inc.
Sep 11, 2018 R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, RE... The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D... Class III R & D Systems, Inc.
Aug 24, 2016 R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative deter... R&D Systems, Inc. received two customer complaints that results of the Controls provided with the... Class II R & D Systems, 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.