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
Sep 30, 2017	Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is a...	Product was released to market without the adulteration strip included in the product.	Class III	Ameditech Inc
Sep 25, 2017	AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the ...	The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information r...	Class III	PerkinElmer Life and Analytical Sciences, Walla...
Sep 21, 2017	Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 006431692...	There is a possibility that specific lots of catheters that have recently been distributed may be...	Class III	Medtronic Neuromodulation
Sep 20, 2017	Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcar...	Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %Do...	Class III	Philips Electronics North America Corporation
Sep 1, 2017	Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (com...	The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister la...	Class III	CooperVision Inc.
Aug 11, 2017	Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)	The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconst...	Class III	Randox Laboratories
Aug 11, 2017	Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)	The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconst...	Class III	Randox Laboratories
Aug 3, 2017	Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501	Complaints were filed claiming the material consistency was too soft and too sticky in comparison...	Class III	Ivoclar Vivadent, Inc.
Aug 3, 2017	Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502	Complaints were filed claiming the material consistency was too soft and too sticky in comparison...	Class III	Ivoclar Vivadent, Inc.
Aug 3, 2017	Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559	Complaints were filed claiming the material consistency was too soft and too sticky in comparison...	Class III	Ivoclar Vivadent, Inc.
Aug 3, 2017	Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503	Complaints were filed claiming the material consistency was too soft and too sticky in comparison...	Class III	Ivoclar Vivadent, Inc.
Aug 2, 2017	JANUS & JANUS G3 Automated Workstation is an automated programmable liquid h...	We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were...	Class III	Perkinelmer Life Sciences, Inc.
Jul 10, 2017	VITROS Chemistry Products Performance Verifier is used as an assayed control ...	VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements fo...	Class III	Ortho Clinical Diagnostics Inc
Jul 10, 2017	Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to ...	Two specific lots was incorrectly manufactured containing a UK power adapter.	Class III	AMEDA, INC.
Jun 26, 2017	Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents incl...	The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes incl...	Class III	Ameditech Inc
Jun 2, 2017	Arctic Sun ArcticGel Pads - Medium, Product Code 317-07	Label on product box contains the incorrect reference #317-09 while the shelf box label with barc...	Class III	C.R. Bard, Inc.
Jun 1, 2017	BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is desi...	Potential unexpected movement of robot arm	Class III	Becton Dickinson & Co.
May 31, 2017	PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collec...	PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pac...	Class III	PerkinElmer Health Sciences, Inc.
May 22, 2017	DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-...	FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit b...	Class III	Euro Diagnostica AB
May 8, 2017	Beekley Medical 0-SPOT Mammography Skin Markers REF 652	Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels	Class III	Beekley Corporation
Apr 27, 2017	Liquid Urine Control Level 3 For Professional Use in the quality control m...	According to Randox Laboratories an investigation indicates a labelling error for 2 of the test m...	Class III	Randox Laboratories
Mar 29, 2017	Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.	Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.	Class III	Teleflex Medical
Mar 2, 2017	LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO...	Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.	Class III	Microbiologics Inc
Mar 2, 2017	KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK...	Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.	Class III	Microbiologics Inc
Feb 24, 2017	BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma c...	The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone...	Class III	Philips Medical Systems (Cleveland) Inc
Feb 23, 2017	ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: ...	Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and ...	Class III	Siemens Healthcare Diagnostics, Inc.
Feb 8, 2017	AIA-PACK TPOAb CONTROL SET	The label contains two different methodologies. Quality Control values for non-FDA approved metho...	Class III	Tosoh Bioscience, Inc.
Feb 8, 2017	AIA-PACK TgAb CONTROL SET	The label contains two different methodologies. Quality Control values for non-FDA approved metho...	Class III	Tosoh Bioscience, Inc.
Jan 30, 2017	Daavlin Aquex (DAAV1000)	The device was reclassified from a class III device to a class II device and there are new docume...	Class III	Hidrex GmbH
Jan 30, 2017	Hidrex USA DVP1000	The device was reclassified from a class III device to a class II device and there are new docume...	Class III	Hidrex GmbH
Jan 30, 2017	Hidrex USA DP450	The device was reclassified from a class III device to a class II device and there are new docume...	Class III	Hidrex GmbH
Jan 25, 2017	DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED W...	DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p...	Class III	DeRoyal Industries Inc
Jan 25, 2017	The UNI-CP System; Model Number: 330230SND.	The firm received one complaint from one non-US sales representative (France) that the label on t...	Class III	Integra LifeSciences Corp.
Jan 25, 2017	SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAI...	DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p...	Class III	DeRoyal Industries Inc
Jan 19, 2017	AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Naso...	Expired expiration dates are listed on the pouches.	Class III	Applied Medical Technology Inc
Jan 19, 2017	AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointesti...	Expired expiration dates are listed on the pouches.	Class III	Applied Medical Technology Inc
Jan 5, 2017	VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, I...	The company received a customer complaint for the inability to calibrate VITROS Chemistry Product...	Class III	Ortho-Clinical Diagnostics
Dec 23, 2016	Optilite IgG4 Kit Product Code: LK009.OPT.A	A change to the lower end of the measuring range and product insert did not reflect the change.Th...	Class III	The Binding Site Group, Ltd.
Dec 21, 2016	AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1...	Beckman Coulter initiated a design change to update the Automate PC image to accommodate the oper...	Class III	Beckman Coulter Inc.
Dec 21, 2016	Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Produc...	AutoDELFIA System with Version 3.0 Software: Potential plate loading failures	Class III	PerkinElmer Health Sciences, Inc.
Dec 21, 2016	DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number...	AutoDELFIA System with Version 3.0 Software: Potential plate loading failures	Class III	PerkinElmer Health Sciences, Inc.
Dec 21, 2016	AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number:...	AutoDELFIA System with Version 3.0 Software: Potential plate loading failures	Class III	PerkinElmer Health Sciences, Inc.
Dec 13, 2016	Roth Net Polyp Retrieval	The firm was notified that the expiration date on the outer carton is different than the expirati...	Class III	US Endoscopy Group Inc
Dec 5, 2016	EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-...	Unique Device Identifier (UDI) is missing from outer kit box label.	Class III	PerkinElmer Health Sciences, Inc.
Nov 30, 2016	Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.	The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the...	Class III	Ecolab Inc
Nov 18, 2016	OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical...	Labeled as a 48mm Cortical Screw but measuring at 50mm	Class III	OrthoPediatrics Corp
Nov 16, 2016	DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum	A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrat...	Class III	PerkinElmer Health Sciences, Inc.
Nov 10, 2016	Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) P...	Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due t...	Class III	OraSure Technologies, Inc.
Nov 7, 2016	Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase I...	Due to a customer experiencing complaints on bone fraction of assay not being in range. The co...	Class III	Helena Laboratories, Inc.
Oct 31, 2016	HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotl...	HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the requir...	Class III	Smiths Medical ASD, 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.