Browse Device Recalls

481 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 481 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 481 FDA device recalls.

Clear

Date	Product	Reason	Class	Firm
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.
Dec 20, 2021	API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualita...	Risk of misidentification or delayed results with the absence of identification due to thermoform...	Class II	Biomerieux Inc
Nov 9, 2021	RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in...	There is an error in the new version of the package insert. The Reading Table lists the incorrec...	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.
Sep 2, 2021	MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System	Under certain conditions, there is a risk for a false negative result.	Class II	BioMerieux SA
Jun 24, 2021	ETEST IMIPENEM RELEBACTAM. in vitro diagnostic	Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeru...	Class II	Biomerieux Inc
Jun 22, 2021	MYLA software. Used to manage microbiology test workflow from the reception ...	Software anomaly - Under certain conditions, unwanted alterations to results could be applied whe...	Class II	BioMerieux SA
Mar 16, 2021	VIDAS¿ CMV IgM 30 Tests	bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM...	Class II	Biomerieux Inc
Jan 28, 2021	VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the ext...	bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes...	Class II	Biomerieux Inc
Jan 28, 2021	VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with...	bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes...	Class II	Biomerieux Inc
Mar 11, 2020	The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VI...	There is a potential for the occurrence of false positive OXSF results for some Staphylococcus au...	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.
Jan 10, 2020	NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerie...	Following a customer complaint about colored eluates, leading to invalid results bioMerieux has c...	Class II	BIOMERIEUX - Grenoble
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.
Oct 22, 2019	BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation	Following Customers complaints, investigations have been initiated on potentially false results o...	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.
Sep 17, 2018	NucliSENS¿ Magnetic Extraction Reagents	Data loggers showed that one shipment to the United States experienced low temperatures that may ...	Class II	BioMerieux SA
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.
Apr 9, 2018	VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux S...	Invalid calibration with low calibrator S1 while using the product.	Class II	BioMerieux SA
Mar 23, 2018	Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and...	A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable...	Class II	BioMerieux SA
Mar 23, 2018	The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to ...	A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable...	Class II	BioMerieux SA
Mar 23, 2018	Oxidase Reagent (ref: 55635): This test is used to detect the production of t...	A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable...	Class II	BioMerieux SA
Mar 23, 2018	The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VI...	A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable...	Class II	BioMerieux SA
Mar 23, 2018	The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for us...	A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable...	Class II	BioMerieux SA

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.