Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016
MEDLINE INDUSTRIES, LP - Northfield
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech
Exactech, Inc.
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
CooperVision Inc.
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implan
Exocad GmbH
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the va
Angiodynamics, Inc.
RAPIDPOINT 500 Blood Gas System
Siemens Healthcare Diagnostics Inc
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Produ
The Binding Site Group, Ltd.
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.
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.
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.
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to eva
Microbiologics 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.
Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central ve
ZOLL Circulation, 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
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