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
Jul 10, 2014	RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, S...	Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date...	Class III	Teleflex Medical
Jul 2, 2014	INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL...	The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re...	Class III	Carestream Health Inc.
Jul 2, 2014	Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DE...	The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned re...	Class III	Carestream Health Inc.
Jun 30, 2014	Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: ...	STERIS has identified that deformation of the washers door handle pin may occur when the door ha...	Class III	Steris Corporation
May 30, 2014	Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoa...	Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family o...	Class III	Alere San Diego, Inc.
May 27, 2014	Dimension¿ Integrated Chemistry Systems intended to measure a variety of anal...	There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Sy...	Class III	Siemens Healthcare Diagnostics, Inc.
May 22, 2014	Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management ...	RAPIDComm¿ 5.0 Screen Layout will display incorrect test names	Class III	Siemens Healthcare Diagnostics Inc
May 21, 2014	BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catal...	A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 322...	Class III	Becton Dickinson & Co.
May 15, 2014	Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial...	The original mean assigned to the control too high, upon reassignment with additional data the ne...	Class III	Medtest Holdings, Inc.
May 13, 2014	Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicate...	Unit was mislabeled with a factory label showing 32 KW output power.	Class III	AGFA Healthcare Corp.
May 13, 2014	DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep...	A limited number of DV5x Series CPAP units were manufactured and shipped without the serial numbe...	Class III	DeVilbiss Healthcare LLC
May 1, 2014	NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with ...	Container cap may contain foreign material- 0.60% - 0.80% Manganese	Class III	Fresenius Medical Care Holdings, Inc.
Apr 25, 2014	VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory s...	The keyboard and monitor may not be properly secured to the monitor arm.	Class III	Siemens Medical Solutions Diagnostics
Apr 17, 2014	APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233...	Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collectio...	Class III	Gen-Probe Inc
Apr 7, 2014	PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebr...	The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a compo...	Class III	Laurimed LLC
Apr 1, 2014	NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.	Device has the potential to have torn wings.	Class III	Nipro Medical Corporation
Mar 18, 2014	Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists...	Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when ...	Class III	Nanosphere, Inc.
Feb 19, 2014	Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes,...	The bar code that is printed on the Master Carton label does not correspond to the product code f...	Class III	Medefil Incorporated
Feb 18, 2014	Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; I...	Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified thro...	Class III	Lin-Zhi International Inc
Feb 17, 2014	TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkst...	If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the ...	Class III	Technidata S.A.
Feb 6, 2014	Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2...	Incorrect master label.	Class III	Medtronic Vascular
Jan 27, 2014	CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-0...	Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return o...	Class III	Cardiovascular Systems, Inc.
Jan 15, 2014	VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATAL...	Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin...	Class III	Ortho-Clinical Diagnostics
Dec 18, 2013	ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-le...	HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine ass...	Class III	Horiba Instruments, Inc dba Horiba Medical
Dec 11, 2013	AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identificat...	Kits incompatible with certain fluorescence microscope light sources	Class III	AdvanDx, Inc.
Dec 2, 2013	MAS Omni Immune PRO Controls	The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; ho...	Class III	Microgenics Corporation
Dec 2, 2013	MAS Omni Immune Controls	The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; ho...	Class III	Microgenics Corporation
Nov 22, 2013	D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. Un...	D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not b...	Class III	Bio-Rad Laboratories, Inc.
Nov 20, 2013	Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straig...	Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scis...	Class III	Edwards Lifesciences, LLC
Nov 19, 2013	Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex...	Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the de...	Class III	Ultradent Products, Inc.
Oct 29, 2013	MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed)...	Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet ...	Class III	Thermofisher Scientive
Oct 23, 2013	Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette,...	Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-99...	Class III	Alere San Diego, Inc.
Oct 21, 2013	da Vinci Vision System Cart, a component of the da Vinci Si Surgical System ...	Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompati...	Class III	Intuitive Surgical, Inc.
Oct 16, 2013	Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid...	Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Inte...	Class III	Nanosphere, Inc.
Oct 3, 2013	ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bo...	Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitut...	Class III	Biomet 3i, LLC
Oct 3, 2013	Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control ...	Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentrati...	Class III	Lin-Zhi International Inc
Oct 3, 2013	STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product cod...	Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not ...	Class III	Advanced Sterilization Products
Oct 1, 2013	Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3	InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV I...	Class III	Helix Medical LLC
Sep 23, 2013	Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Cont...	Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN ...	Class III	Alere San Diego, Inc.
Sep 6, 2013	ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essentia...	HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting ...	Class III	Horiba Instruments, Inc dba Horiba Medical
Sep 3, 2013	King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult...	Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to ...	Class III	King Systems Corp.
Aug 20, 2013	FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or...	The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data fr...	Class III	Bio-Rad Laboratories
Aug 16, 2013	ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 ...	PTH Calibrator packaged with only high calibrator.	Class III	Siemens Healthcare Diagnostics, Inc
Aug 9, 2013	WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrumen...	The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia...	Class III	Copan Italia
Jul 24, 2013	ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operatin...	An odor and smoke developed - The cause was determined to be a power supply unit sitting in the c...	Class III	Trumpf Medical Systems
Jul 16, 2013	Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (...	Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. ...	Class III	Zoll Circulation, Inc.
Jul 12, 2013	OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution cont...	The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the ...	Class III	Celera Corporation
Jun 28, 2013	ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04...	Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 A...	Class III	Siemens Healthcare Diagnostics, Inc
Jun 25, 2013	ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage f...	ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu...	Class III	Convatec Inc.
Jun 25, 2013	ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage:...	ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu...	Class III	Convatec 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.