Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Leica Microsystems, Inc.
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Medical Devices·876 affected·Sep 17, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MC
Medical Devices·18 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Medical Devices·1,166 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Medical Devices·276 affected·Sep 14, 2018
CriticalFDA
Roche Diagnostics Corporation
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strip...
Medical Devices·1,163,952 affected·Sep 13, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Medical Devices·152 affected·Sep 13, 2018
High RiskFDA
Synthes (usa) Products Llc
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intend...
Medical Devices·20 affected·Sep 12, 2018
High RiskFDA
Cmp Industries, Llc
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Li...
Medical Devices·400 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a ...
Medical Devices·158,163 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·281,350 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·136,800 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a...
Medical Devices·456,071 affected·Sep 12, 2018
High RiskFDA
Cmp Industries, Llc
Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin...
Medical Devices·40 affected·Sep 12, 2018
High RiskFDA
Howmedica Osteonics Corp.
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrume...
Medical Devices·58 affected·Sep 12, 2018
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to ...
Medical Devices·110,134 affected·Sep 12, 2018
RecallFDA
R & D Systems, Inc.
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Medical Devices·8 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for...
Medical Devices·28,004 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording...
Medical Devices·6,458 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording ...
Medical Devices·6,864 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit ...
Medical Devices·33,065 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare Biosciences
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for...
Medical Devices·39 affected·Sep 10, 2018
High RiskFDA
Vivorte, Inc.
Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system Model Number: 130703-10
Medical Devices·12 affected·Sep 9, 2018
High RiskFDA
Abbott Laboratories, Inc
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Medical Devices·159 affected·Sep 7, 2018
High RiskFDA
Bayer Medical Care, Inc.
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product ...
Medical Devices·1,142,836 affected·Sep 7, 2018
CriticalFDA
Stihler Electronic Gmbh
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer...
Medical Devices·1 affected·Sep 6, 2018
CriticalFDA
Stihler Electronic Gmbh
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer i...
Medical Devices·821 affected·Sep 6, 2018
High RiskFDA
Cryolife, Inc.
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Medical Devices·1 affected·Sep 6, 2018
High RiskFDA
Thoratec Switzerland Gmbh
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Medical Devices·1,569 affected·Sep 5, 2018
High RiskFDA
Coopersurgical, Inc.
Colpo-Pneumo Occluder, Part CPO-6
Medical Devices·32,538 affected·Sep 4, 2018
High RiskFDA
Coopersurgical, Inc.
Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316...
Medical Devices·18,000 affected·Sep 4, 2018
High RiskFDA
Widex A/s
Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not ...
Medical Devices·2 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·182,640 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·3,864 affected·Aug 31, 2018
High RiskFDA
Accuray Incorporated
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Medical Devices·259 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·73,673 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·182,640 affected·Aug 31, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging ...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
Medical Devices·1 affected·Aug 30, 2018
High RiskFDA
Medline Industries Inc
Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a f...
Medical Devices·113,302 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imagi...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Urine Collection Cups, Cat. No. 364941
Medical Devices·29,982,150 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Becton Dickinson & Company
KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
Medical Devices·29,982,150 affected·Aug 30, 2018
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Medical Devices·5 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The ...
Medical Devices·596 affected·Aug 30, 2018
High RiskFDA
Arrow International Inc
Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) cent...
Medical Devices·105 affected·Aug 30, 2018
High RiskFDA
Medtronic Navigation, Inc.-littleton
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imagi...
Medical Devices·596 affected·Aug 30, 2018