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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Dec 20, 2024 Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein... Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. Class II Randox Laboratories, Limited
Dec 20, 2024 Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein ... Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. Class II Randox Laboratories, Limited
Dec 19, 2019 RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041... Software version UI2550642107 for the RX Daytona + instrument released to correct the following i... Class II Randox Laboratories, Limited
Oct 4, 2019 Randox Liquid Cardiac Controls Catalogue Number CQ5052. Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an ob... Class II Randox Laboratories, Limited
Oct 4, 2019 Randox Liquid Cardiac Controls Catalogue Number CQ5051 Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an obser... Class II Randox Laboratories, Limited
Oct 4, 2019 Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an ob... Class II Randox Laboratories, Limited
Sep 23, 2019 RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and sh... Class III Randox Laboratories, Limited
Jun 24, 2019 RX Imola, Model Nos. RX4900 There was a report of a malfunction with the sensor which resulted in an increase of temperature ... Class II Randox Laboratories, Limited
Jun 24, 2019 RX Daytona, Model Nos. RX4040 and RX4041 There was a report of a malfunction with the sensor which resulted in an increase of temperature ... Class II Randox Laboratories, Limited
Jun 11, 2019 Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This pr... The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate a... Class II Randox Laboratories, Limited
Jun 10, 2019 Assayed Bovine Multi-Sera Level 1, Model No. AL1027 The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generat... Class III Randox Laboratories, Limited
Aug 8, 2017 Liquid Cardiac Control CQ5053 Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot ... Class II Randox Laboratories, Limited
Apr 14, 2016 Magnesium on RX Imola analyser IVD According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run... Class II Randox Laboratories, Limited

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.