Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
4,100 total recalls
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, In
BioFire Diagnostics, LLC
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Datascope Corp.
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hys
CooperSurgical, Inc.
GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
Mckesson Medical-Surgical Inc. Corporate Office
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
CareFusion 303, Inc.
PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and
TEI Biosciences, Inc.
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. F
Cook Incorporated
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE
MEDLINE INDUSTRIES, LP - Northfield
Baxter Stationary column TruSystem 7500, Product Code 1717020
Baxter Healthcare Corporation
Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Hobbs Medical, Inc.
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Abiomed, Inc.
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra
Integra LifeSciences Corp.
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001876;
Beaver Visitec International, Inc.
Senior Living Arial Emergency and Nurse Call Systems
Stanley Security Solutions Inc
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
GE Healthcare GmbH
VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
Biomerieux Inc
PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
Biomerieux Inc
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Shanghai United Imaging Healthcare Co., Ltd.
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Datascope Corp.
Medtronic DLP Vessel Cannula, Model Number REF 30000
Medtronic Perfusion Systems
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02
Flexicare Medical (Dongguan) Ltd.
DeRoyal EYE TRAY, REF 89-4957.08
DeRoyal Industries Inc
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodiu
Siemens Healthcare Diagnostics, Inc.
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Boston Scientific Corporation
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL9
Medline Industries, LP
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
American Contract Systems Inc
Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09
AVID Medical, Inc.
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152.
Cook Incorporated
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
Getinge Usa Sales Inc
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