Browse Device Recalls

1,023 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,023 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 1,023 FDA device recalls — Class III.

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Date	Product	Reason	Class	Firm
Feb 27, 2015	Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL IN...	Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.	Class III	Volk Optical Inc
Feb 27, 2015	Lombart 90D Clear with case Visualization during diagnosis and laser therapy...	Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct l...	Class III	Volk Optical Inc
Feb 25, 2015	Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per ...	The outer carton label and package insert for the recalled product incorrectly lists Streptococcu...	Class III	Biomerieux Inc
Feb 25, 2015	Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per ...	The outer carton label and package insert for the recalled product incorrectly lists Streptococcu...	Class III	Biomerieux Inc
Feb 25, 2015	Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per ...	The outer carton label and package insert for the recalled product incorrectly lists Streptococcu...	Class III	Biomerieux Inc
Feb 24, 2015	LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI Syste...	Mislabeled with an incorrect expiration date	Class III	LeMaitre Vascular, Inc.
Feb 19, 2015	Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon...	The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as...	Class III	Richard-Allan Scientific Company
Feb 19, 2015	ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a hu...	Outer shipping carton was marked with an incorrect expiry date, however inner product carton was ...	Class III	Arc Medical Inc
Feb 11, 2015	Milestone Wand STA Handpiece for the delivery of local anesthesia to dental t...	Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the ST...	Class III	Milestone Scientific, Inc.
Feb 10, 2015	G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glyc...	The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of Oct...	Class III	Tosoh Bioscience, Inc.
Jan 15, 2015	N Latex IgM; In-vitro diagnostic reagent for the quantitative determination o...	Complaints have been confirmed on failed proficiency testing due to serum samples recovering too ...	Class III	Siemens Healthcare Diagnostics, Inc.
Jan 13, 2015	cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA a...	False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mu...	Class III	Roche Molecular Systems, Inc.
Jan 9, 2015	Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial ...	Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the inco...	Class III	Arrow International Inc
Jan 9, 2015	Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operatin...	Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon us...	Class III	Alivecor SFO
Dec 22, 2014	Flyte Togas are components of the Stryker Flyte System and are intended to be...	A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled...	Class III	Stryker Instruments Div. of Stryker Corporation
Dec 18, 2014	cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Inten...	cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS C...	Class III	Roche Molecular Systems, Inc.
Dec 17, 2014	Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Hep...	The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit L...	Class III	Smiths Medical ASD, Inc.
Dec 12, 2014	Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro dia...	Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 ...	Class III	Pointe Scientific, Inc.
Nov 26, 2014	VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as Co...	Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon conta...	Class III	Lacrimedics Inc
Nov 17, 2014	Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 80...	Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture ...	Class III	Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 11, 2014	Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is int...	Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing p...	Class III	Aesculap, Inc.
Nov 10, 2014	CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software...	The firm is informing customers of a software error that might result in an inaccurate display of...	Class III	Medtronic MiniMed Inc.
Nov 10, 2014	Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reade...	Incorrect lumi firmware version installed (E.027 instead of V2.00)	Class III	Tecan US, Inc.
Nov 10, 2014	Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader w...	Incorrect lumi firmware version installed (E.027 instead of V2.00)	Class III	Tecan US, Inc.
Nov 6, 2014	Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnost...	Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when u...	Class III	Illumina Inc
Nov 4, 2014	LUNA Chest, Model No. LU4006	Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.	Class III	Novadaq Technologies, Inc.
Nov 4, 2014	Non-sterile drape	Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.	Class III	Novadaq Technologies, Inc.
Oct 27, 2014	Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgic...	The product has been identified to contain an incorrect curette type.	Class III	CooperSurgical, Inc.
Oct 24, 2014	Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12...	Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin lin...	Class III	AGFA Healthcare Corp.
Oct 23, 2014	MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC...	MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values...	Class III	Medtest Holdings, Inc.
Oct 20, 2014	IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, I...	A typographical error regarding the expiration date was identified in the control module instruct...	Class III	Siemens Healthcare Diagnostics, Inc.
Oct 16, 2014	Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility T...	The products have a wrong expiration date on their labeling, 5 years instead of 2 years.	Class III	Biomerieux
Oct 16, 2014	Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Te...	The products have a wrong expiration date on their labeling, 5 years instead of 2 years.	Class III	Biomerieux
Oct 16, 2014	Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te...	The products have a wrong expiration date on their labeling, 5 years instead of 2 years.	Class III	Biomerieux
Oct 16, 2014	Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Te...	The products have a wrong expiration date on their labeling, 5 years instead of 2 years.	Class III	Biomerieux
Oct 16, 2014	Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te...	The products have a wrong expiration date on their labeling, 5 years instead of 2 years.	Class III	Biomerieux
Oct 6, 2014	ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative deter...	Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Ce...	Class III	Siemens Healthcare Diagnostics, Inc
Sep 30, 2014	CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Mode...	Incorrect expiration date printed on the MILEX PESSARY KIT packaging	Class III	CooperSurgical, Inc.
Sep 30, 2014	CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: ...	Incorrect expiration date printed on the MILEX PESSARY KIT packaging	Class III	CooperSurgical, Inc.
Sep 29, 2014	VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemis...	Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Prod...	Class III	Ortho-Clinical Diagnostics
Sep 17, 2014	ProClear Toric contact lenses are made from a material containing 62%...	Routine quality monitoring system has identified that a limited number of lots were manufactured...	Class III	Cooper Vision Caribbean Corp.
Sep 12, 2014	Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roch...	The default references for normal values are inconsistent between cobas b 221 and other blood gas...	Class III	Roche Diagnostics Operations, Inc.
Sep 12, 2014	ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution ...	Stability of the ADVIA Centaur Cleaning Solution is not assured	Class III	Siemens Healthcare Diagnostics, Inc
Sep 8, 2014	Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Cou...	Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound d...	Class III	Coloplast Manufacturing US, LLC
Aug 13, 2014	JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument ...	BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because th...	Class III	Biofire Defense
Aug 11, 2014	ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. ...	Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing tha...	Class III	ELITech Clinical Systems SAS
Aug 11, 2014	LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group	During label reconciliation a duplicate serial number label was detected to be printed for the LI...	Class III	Datascope Corporation
Jul 18, 2014	Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kit...	Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (sub...	Class III	Diagnostica Stago, Inc.
Jul 18, 2014	BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete ...	The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be ...	Class III	BD Biosciences, Systems & Reagents
Jul 16, 2014	Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355;...	Some sheets of the medical screen film are fogged.	Class III	AGFA Healthcare Corp.

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.