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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Oct 1, 2025 Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control,... The firm received complaints from customers reporting vial-to-vial variability when using the con... Class II Microgenics Corporation
Jan 20, 2022 QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL ... Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting i... Class II Microgenics Corporation
Aug 15, 2016 Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribut... A reagent stability issue (still under investigation) causes less separation in the calibration c... Class II Microgenics Corporation
Jul 25, 2016 DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI ... Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than t... Class II Microgenics Corporation
Oct 20, 2014 MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for ... MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes C... Class II Microgenics Corporation
Dec 2, 2013 MAS Omni Immune Controls The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; ho... Class III Microgenics Corporation
Dec 2, 2013 MAS Omni Immune PRO Controls The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; ho... Class III Microgenics Corporation
Oct 29, 2013 MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed)... Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet ... Class III Thermofisher Scientive
Oct 16, 2013 Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog... Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot ... Class II Microgenics Corp
Jul 23, 2013 DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott L... Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an un... Class II Microgenics Corp
May 13, 2013 Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Pr... It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TB... Class II Microgenics Corporation
Aug 20, 2012 Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integr... In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO... Class III Microgenics Corporation

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.