Browse Device Recalls

46 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 46 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 46 FDA device recalls.

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Date	Product	Reason	Class	Firm
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 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
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
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
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
Mar 23, 2018	The VITEK 2 Gram-Positive identification card (GP) is intended for use with t...	A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable...	Class II	BioMerieux SA
Mar 23, 2018	VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS ...	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 Anaerobic and Corynebacteria identification card (ANC) is intend...	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 Positive Susceptibility Card is intended for use with the V...	A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable...	Class II	BioMerieux SA
Oct 18, 2017	NucliSENS Lysis Buffer Extended lot for RES 76675	Elute may become colored due to the residual presence of heme group origination from hemoglobin p...	Class II	BioMerieux SA
Apr 25, 2017	ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a qu...	False susceptible results	Class II	BioMerieux SA
Apr 13, 2017	ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative techn...	QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Fo...	Class II	BioMerieux SA
Apr 13, 2017	ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative tec...	QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Fo...	Class II	BioMerieux SA
Mar 17, 2017	VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) as...	Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated e...	Class II	BioMerieux SA
Mar 7, 2017	NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be ...	Problem with colored eluates for whole blood extractions	Class II	BioMerieux SA
Jan 18, 2017	ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is...	Potential performance issues. False Susceptible result instead of Intermediate and False Interme...	Class II	BioMerieux SA
Jan 11, 2017	VIDAS 3 software v. 1.1.4	During development of the VIDAS 3 software version 1.2, some anomalies have been identified and o...	Class II	BioMerieux SA
Jan 1, 2017	Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 50705...	Potential performance issue on strain categorization.	Class II	BioMerieux SA
Dec 15, 2016	ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(lo...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32....	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM ...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.01...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenic...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0....	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.00...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.01...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0....	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.0...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0....	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Dec 15, 2016	ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.00...	Product Stability issues: The current shelf-life claims of the ETEST products are not supported ...	Class II	BioMerieux SA
Nov 23, 2016	MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS...	A drift of the performance with the BK test (BK virus, worst case application) was observed for s...	Class I	BioMerieux SA
Nov 23, 2016	NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Prod...	A drift of the performance with the BK test (BK virus, worst case application) was observed for s...	Class I	BioMerieux SA
Jul 8, 2016	NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products...	Several customer complaints about amplification performance issues when using different batches o...	Class I	BioMerieux SA
Jan 8, 2016	API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional tes...	Discrepant identification results related to API identification strips. These discrepant identif...	Class II	BioMerieux SA
Jun 12, 2015	Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.	QC results were out of range resulting in false resistant strains.	Class II	BioMerieux SA
Mar 6, 2014	API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (...	bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ...	Class II	BioMerieux SA
Mar 6, 2014	FB Reagent (REF 70562). FB reagent is an additional test used for revealin...	bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ...	Class II	BioMerieux SA
Mar 6, 2014	API Listeria (REF 10300). ZYM B reagent is used and included inside of API...	bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ...	Class II	BioMerieux SA
Mar 6, 2014	ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to...	bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ...	Class II	BioMerieux SA
Oct 14, 2013	VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measure...	Product is not approved or authorized for distribution in the US.	Class II	BioMerieux SA
Apr 17, 2013	VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instrum...	Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefor...	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.