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.

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Date	Product	Reason	Class	Firm
Apr 20, 2017	VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards p...	The integrity of the product container may be compromised thereby exposing product to moisture wh...	Class II	Biomerieux Inc
Apr 20, 2017	VITEK¿ 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards pe...	The integrity of the product container may be compromised thereby exposing product to moisture wh...	Class II	Biomerieux Inc
Apr 20, 2017	VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 ca...	The integrity of the product container may be compromised thereby exposing product to moisture wh...	Class II	Biomerieux Inc
Apr 20, 2017	VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 ca...	The integrity of the product container may be compromised thereby exposing product to moisture wh...	Class II	Biomerieux Inc
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
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.
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
Sep 16, 2016	The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid c...	An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20%...	Class II	Randox Laboratories
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
Apr 15, 2016	VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated qu...	Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.	Class III	Biomerieux France Chemin De L'Or
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Ca...	Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. a...	Class II	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 car...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
Feb 24, 2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 ca...	Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp...	Class I	Biomerieux Inc
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
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 23, 2015	Granada Biphasic Broth The product is a selective medium for the screening...	FDA has determined that the product requires 510(k) clearance to continue marketing/distribution ...	Class II	Biomerieux Inc
Nov 19, 2015	Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW ...	Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa...	Class I	Biomerieux
Nov 19, 2015	Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantita...	Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa...	Class I	Biomerieux
Nov 19, 2015	Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitati...	Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa...	Class I	Biomerieux
Nov 19, 2015	Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantita...	Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa...	Class I	Biomerieux
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.

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.