Browse Device Recalls
55 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 55 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 55 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 26, 2025 | VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation ... | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas ... | Class II | bioMerieux, Inc. |
| Jul 20, 2022 | NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. | There is a potential of no result leading to possible delayed result due to contamination of extr... | Class II | bioMerieux, Inc. |
| Jul 13, 2022 | VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only),... | There are 7 reported software anomalies that may affect use of the device. | Class II | bioMerieux, Inc. |
| Mar 29, 2022 | VITEK 2 Systems and VITEK 2 with MYLA. | Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and syner... | Class II | bioMerieux, Inc. |
| Feb 9, 2022 | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. | Invalid calibrations (out of range high) while using the product. | Class II | bioMerieux, Inc. |
| Sep 30, 2021 | API 50 CH, Model 50300 | There is potential to provide an incorrect organism identification. | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS SARS-COV-2 IgG, Ref 423834-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS Mumps IgG (MPG), REF 30218 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS Lyme IgM II (LYM), REF 416436 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS DEX@, Dimer Exclusion II, REF 30455-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS Clostridium Difficile GDH, REF 30125-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS Measles IgG (MSG), REF 30219 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS LH, REF 30406-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS PRG Progesterone, REF 30409-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS Lyme IgG II (LYM), REF 417401 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS Estradiol II, REF 30431-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS TOXO IgG Avidity (TXGA), REF 30222-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS SARS-COV-2 IgM, Ref 423833-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS FSH, REF 30407-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS RUB IgG (RBG), REF 30226 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Feb 5, 2020 | VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system con... | The top seal of some of the pouches was compromised which can allow moisture to enter that can im... | Class II | bioMerieux, Inc. |
| Jan 24, 2020 | PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units... | The recall has been initiated due to potential for overheating or a fire hazard associated with ... | Class II | bioMerieux, Inc. |
| Dec 10, 2019 | VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit | Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which ... | Class II | bioMerieux, Inc. |
| Mar 15, 2019 | Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of ... | Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherich... | Class II | bioMerieux, Inc. |
| Dec 13, 2018 | VITEK 2 AST-N351 Test Kit | False Positive ESBL Phenotype | Class II | bioMerieux, Inc. |
| Nov 13, 2018 | VITEK¿ 2 Systems Software Version 9.01 Update Kit. | The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification... | Class II | bioMerieux, Inc. |
| Oct 22, 2018 | VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these... | False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were r... | Class II | bioMerieux, Inc. |
| Oct 8, 2018 | bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134 | Some eluates become colored because of remaining hemoglobin in the eluate. | Class II | bioMerieux, Inc. |
| Aug 13, 2018 | VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Entero... | Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were ma... | Class II | bioMerieux, Inc. |
| Aug 13, 2018 | VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Entero... | Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were ma... | Class II | bioMerieux, Inc. |
| Jun 27, 2018 | BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage... | The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... | Class II | bioMerieux, Inc. |
| Jun 27, 2018 | BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product... | The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... | Class II | bioMerieux, Inc. |
| Jun 27, 2018 | BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage... | The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... | Class II | bioMerieux, Inc. |
| Mar 1, 2018 | VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is... | Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS... | Class II | bioMerieux, Inc. |
| Jan 26, 2018 | bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST ... | Customer reports indicated an increase in the rate of non-detected MRSA in association with the V... | Class I | bioMerieux, Inc. |
| Jan 4, 2018 | BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*... | Increase of events affecting performance regarding pump clogging and displacement of the color-co... | Class II | bioMerieux, Inc. |
| Jan 4, 2018 | BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) ... | Increase of events affecting performance regarding pump clogging and displacement of the color-co... | Class II | bioMerieux, Inc. |
| Aug 25, 2017 | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R)... | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus... | Class II | Biomerieux Inc |
| May 15, 2017 | VIDAS Testosterone, Ref 30418 | Complaints were received from customers observing falsely overestimate results or external qualit... | Class II | bioMerieux, Inc. |
| Apr 10, 2017 | eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intend... | Some anomalies have been identified during manufacturing controls. | Class II | bioMerieux, Inc. |
| Dec 24, 2015 | BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bott... | Bottles may have been exposed to non-normal shipping conditions which may lead to media degradati... | Class II | bioMerieux, Inc. |
| Dec 24, 2015 | BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottl... | Bottles may have been exposed to non-normal shipping conditions which may lead to media degradati... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application ... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer appl... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer appl... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer applicati... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, 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.