Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·5,004 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·400 affected·Feb 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Syst...
Medical Devices·1,012 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·21,326 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·2,632 affected·Feb 18, 2020
High RiskFDA
Beckman Coulter, Inc.
iChemVELOCITY Strips, Catalog 800-7212
Medical Devices·10,822 affected·Feb 17, 2020
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Medical Devices·1,050 affected·Feb 14, 2020
High RiskFDA
Sunrise Medical (us) Llc
Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A...
Medical Devices·1 affected·Feb 13, 2020
High RiskFDA
Microbiologics Inc
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845...
Medical Devices·49 affected·Feb 12, 2020
High RiskFDA
Medtronic Ats Medical, Inc.
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Medical Devices·2 affected·Feb 11, 2020
High RiskFDA
Change Healthcare Canada Company
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Medical Devices·51 affected·Feb 10, 2020
High RiskFDA
Carolina Liquid Chemistries Corp
SPICE (JWH-018) CC443
Medical Devices·0 affected·Feb 10, 2020
High RiskFDA
Agfa N.v.
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to sy...
Medical Devices·2 affected·Feb 10, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Medical Devices·81 affected·Feb 10, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Medical Devices·146 affected·Feb 10, 2020
High RiskFDA
Medline Industries Inc
Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
Medical Devices·1,541,532 affected·Feb 10, 2020
RecallFDA
Integra Lifesciences Corp.
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of pe...
Medical Devices·55 affected·Feb 7, 2020
High RiskFDA
Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Medical Devices·2,471 affected·Feb 6, 2020
High RiskFDA
Invivo Corporation
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Medical Devices·75 affected·Feb 6, 2020
High RiskFDA
Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
Medical Devices·555 affected·Feb 6, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Medical Devices·870,070 affected·Feb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris PCA Module, Model 8120
Medical Devices·83,015 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Medical Devices·2,100 affected·Feb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris Pump Module, Model 8100
Medical Devices·1,286,898 affected·Feb 4, 2020
CriticalFDA
Carefusion 303, Inc.
CareFusion Alaris Syringe Module, Model 8110
Medical Devices·114,835 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Medical Devices·2,100 affected·Feb 4, 2020
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point...
Medical Devices·3,968 affected·Feb 3, 2020
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory e...
Medical Devices·12,822 affected·Feb 3, 2020
High RiskFDA
89 North
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
Medical Devices·188 affected·Jan 31, 2020
High RiskFDA
Organ Recovery Systems, Inc.
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidn...
Medical Devices·2,274 affected·Jan 30, 2020
High RiskFDA
Inova Lasers Llc
Class IV New Era medical laser device
Medical Devices·8 affected·Jan 29, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T ...
Medical Devices·3,561 affected·Jan 29, 2020
High RiskFDA
Medtronic, Plc
McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-...
Medical Devices·109,897 affected·Jan 28, 2020
High RiskFDA
Medicrea International
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B...
Medical Devices·3,529 affected·Jan 28, 2020
High RiskFDA
Fridababy Llc
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Medical Devices·480,144 affected·Jan 27, 2020
High RiskFDA
Abbott Gmbh & Co. Kg
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity ...
Medical Devices·2,676 affected·Jan 24, 2020
High RiskFDA
Braemar Manufacturing, Llc
Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Medical Devices·10,582 affected·Jan 22, 2020
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part n...
Medical Devices·16,700 affected·Jan 22, 2020
CriticalFDA
Sysmex America, Inc.
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Medical Devices·40 affected·Jan 21, 2020
High RiskFDA
Medline Industries Inc
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Medical Devices·122 affected·Jan 21, 2020
High RiskFDA
Hologic, Inc.
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Medical Devices·72 affected·Jan 21, 2020
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
FlipCutter III Drill
Medical Devices·6,625 affected·Jan 20, 2020
High RiskFDA
Ehob, Inc.
Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product...
Medical Devices·0 affected·Jan 19, 2020