Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
4,100 total recalls
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Philips North America
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
MEDLINE INDUSTRIES, LP - Northfield
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Mckesson Medical-Surgical Inc. Corporate Office
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
Orascoptic Surgical Acuity
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Numbe
Siemens Medical Solutions USA, Inc
ProCuity bed series, model number 3009, item number: 3009PX-L-100.
Stryker Medical Division of Stryker Corporation
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (18
Boston Scientific Corporation
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human s
Siemens Healthcare Diagnostics, Inc.
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Gr
Bolton Medical Inc.
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Philips North America Llc
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The
Beckman Coulter, Inc.
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
American Contract Systems, Inc.
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
AVID Medical, Inc.
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Cardinal Health 200, LLC
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Int
Cook Inc.
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Intuitive Surgical, Inc.
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
Oscor Inc.
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
Flexicare Medical (Dongguan) Ltd.
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H
GE Medical Systems, LLC
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111
Smiths Medical ASD, Inc.
AcuMatch Hip System, Catalog Number 142-32-27
Exactech, Inc.
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
Unetixs Vascular, Inc.
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Ossur H / F
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S
Medline Industries, LP
Infinity FMS Pak
Alcon Research, LTD.
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON
Jiangsu Shenli Medical Production Co., Ltd.
ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and sta
Zimmer, Inc.
Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
AVID Medical, Inc.
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Olympus Corporation of the Americas
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