Browse Device Recalls
27 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 27 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 27 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 30, 2025 | Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Plate... | Due to a risk of false positive results that could lead to unnecessary medical treatment. | Class II | Bio-Rad Laboratories, Inc. |
| Feb 15, 2024 | Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit | Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower ... | Class II | Bio-Rad Laboratories |
| Feb 28, 2023 | BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack | APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase... | Class II | Bio-Rad Laboratories, Inc. |
| Feb 21, 2023 | BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP ... | Class II | Bio-Rad Laboratories, Inc. |
| Feb 21, 2023 | BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP ... | Class II | Bio-Rad Laboratories, Inc. |
| Oct 19, 2022 | CMV IgM EIA, in vitro diagnostic. | Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (C... | Class II | Bio-Rad Laboratories, Inc. |
| Apr 14, 2022 | BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack | Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated backgro... | Class II | Bio-Rad Laboratories, Inc. |
| Apr 7, 2022 | Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reor... | The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Mod... | Class II | Bio-Rad Laboratories, Inc. |
| Feb 8, 2022 | BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL | Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioP... | Class II | Bio-Rad Laboratories, Inc. |
| Feb 8, 2022 | BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack | Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioP... | Class II | Bio-Rad Laboratories, Inc. |
| Sep 17, 2021 | BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pa... | Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reag... | Class II | Bio-Rad Laboratories, Inc. |
| Sep 17, 2021 | BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL T... | Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reag... | Class II | Bio-Rad Laboratories, Inc. |
| Apr 21, 2020 | BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pa... | The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material numbe... | Class II | Bio-Rad Laboratories, Inc. |
| Nov 1, 2019 | BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Scre... | A new lot of ANA screen control and any subsequent control lots are incompatible with older lot n... | Class II | Bio-Rad Laboratories, Inc. |
| Jan 10, 2019 | EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management S... | User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling ... | Class II | Bio-Rad Laboratories, Inc |
| Jun 8, 2018 | MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is ... | Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. | Class II | Bio-Rad Laboratories, Inc |
| Jun 8, 2018 | MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASele... | Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. | Class II | Bio-Rad Laboratories, Inc |
| Apr 2, 2018 | PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The P... | The connector of the power supply was capable of fitting other components provided with the syste... | Class II | Bio-Rad Laboratories Inc |
| Dec 22, 2015 | EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS O... | The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the... | Class II | Bio-Rad Laboratories, Inc. |
| Dec 15, 2015 | D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully ... | On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID whe... | Class II | Bio-Rad Laboratories, Inc. |
| May 13, 2015 | The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 261... | The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the exp... | Class III | Bio-Rad Laboratories, Inc. |
| Apr 8, 2014 | Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) ... | There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Cal... | Class II | Bio-Rad Laboratories, Inc. |
| Feb 27, 2014 | D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by:... | On a rare occasion the D-10 software might generate an extra result by duplicating the result for... | Class II | Bio-Rad Laboratories, Inc. |
| Nov 22, 2013 | D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. Un... | D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not b... | Class III | Bio-Rad Laboratories, Inc. |
| Aug 20, 2013 | FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or... | The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data fr... | Class III | Bio-Rad Laboratories |
| Apr 15, 2013 | Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Cont... | The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which ori... | Class III | Bio-rad Laboratories, Inc. |
| Jul 27, 2012 | The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has t... | Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result i... | Class II | Bio-Rad Laboratories |
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.