Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Beckman Coulter Inc.
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and pos...
Medical Devices·468 affected·Apr 11, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc.
E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the follo...
Medical Devices·4,856 affected·Apr 11, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the follow...
Medical Devices·419 affected·Apr 11, 2012
CriticalFDA
Ge Healthcare, Llc
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
Medical Devices·8 affected·Apr 10, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009...
Medical Devices·70 affected·Apr 10, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-0...
Medical Devices·70 affected·Apr 10, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create ...
Medical Devices·2 affected·Apr 9, 2012
CriticalFDA
Etac Supply Center Ab
Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These products are four-wheeled walkers intended as a walking aid for i...
Medical Devices·204,323 affected·Apr 6, 2012
CriticalFDA
Invacare Corporation
TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD...
Medical Devices·665 affected·Apr 6, 2012
High RiskFDA
Hill-rom, Inc.
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of...
Medical Devices·12,726 affected·Apr 2, 2012
High RiskFDA
Greiner Bio-one North America, Inc.
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used onl...
Medical Devices·19 affected·Apr 2, 2012
RecallFDA
Impact Instrumentation, Inc.
Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
Medical Devices·2 affected·Mar 30, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material...
Medical Devices·6,439 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone materia...
Medical Devices·6,439 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, ...
Medical Devices·6,439 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting...
Medical Devices·163 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone materia...
Medical Devices·574 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material...
Medical Devices·68 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone materia...
Medical Devices·6,439 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, p...
Medical Devices·6,439 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Medical Devices·492 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone materia...
Medical Devices·6,439 affected·Mar 29, 2012
CriticalFDA
Fresenius Medical Care Holdings, Inc.
Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2...
Medical Devices·0 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, ...
Medical Devices·6,439 affected·Mar 29, 2012
CriticalFDA
Fresenius Medical Care Holdings, Inc.
Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-...
Medical Devices·0 affected·Mar 29, 2012
High RiskFDA
Maquet Cardiovascular, Llc
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide tempora...
Medical Devices·29 affected·Mar 27, 2012
High RiskFDA
Topcon Medical Laser Systems, Inc
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Medical Devices·7 affected·Mar 27, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Medical Devices·318 affected·Mar 27, 2012
High RiskFDA
Nidek Inc
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like di...
Medical Devices·16 affected·Mar 27, 2012
High RiskFDA
Tango3 Llc
TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE,...
Medical Devices·44 affected·Mar 26, 2012
High RiskFDA
Colgate Palmolive Company
Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft UPC 03500068762 Dist. by Colgate-Palmolive Co. New York, N...
Medical Devices·280,044 affected·Mar 23, 2012
High RiskFDA
Colgate Palmolive Company
Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For te...
Medical Devices·6,006 affected·Mar 23, 2012
High RiskFDA
Colgate Palmolive Company
Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made ...
Medical Devices·280,044 affected·Mar 23, 2012
High RiskFDA
B. Braun Medical, Inc.
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to s...
Medical Devices·13,078 affected·Mar 23, 2012
High RiskFDA
Colgate Palmolive Company
Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made...
Medical Devices·280,044 affected·Mar 23, 2012
High RiskFDA
Tripath Imaging, Inc.
PrepStain Syringing Pipettes 240 (Catalog #490517)
Medical Devices·46,112,784 affected·Mar 22, 2012
High RiskFDA
Tripath Imaging, Inc.
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syr...
Medical Devices·46,112,784 affected·Mar 22, 2012
High RiskFDA
Sunquest Information Systems, Inc.
Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is ...
Medical Devices·126 affected·Mar 15, 2012
High RiskFDA
Surgical Tissue Network, Inc.
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Huma...
Medical Devices·208 affected·Mar 14, 2012
High RiskFDA
Surgical Tissue Network, Inc.
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Hu...
Medical Devices·160 affected·Mar 14, 2012
High RiskFDA
Surgical Tissue Network, Inc.
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tis...
Medical Devices·25 affected·Mar 14, 2012
High RiskFDA
Advanced Sterilization Products
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Medical Devices·2,457 affected·Mar 13, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electro...
Medical Devices·376 affected·Mar 12, 2012
High RiskFDA
Aesculap Implant Systems Llc
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical ...
Medical Devices·15 affected·Mar 7, 2012
RecallFDA
Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD,...
Medical Devices·225 affected·Mar 5, 2012
High RiskFDA
Abbott Point Of Care Inc.
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receivi...
Medical Devices·2,950,296 affected·Mar 1, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo.plaza. Radiological image processing system
Medical Devices·2 affected·Feb 24, 2012
High RiskFDA
Biomet Spine, Llc
Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum ...
Medical Devices·213 affected·Feb 22, 2012