Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,640 total recalls
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Stryker Sustainability Solutions
MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Megadyne Medical Products, Inc.
DeRoyal SHOULDER KIT, REF 89-9497.08
DeRoyal Industries Inc
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet
Boston Scientific Corporation
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthc
Turbett Surgical, Inc.
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
GE Medical Systems China Co., Ltd.
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. No
Cardiac Assist, Inc
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
Linkbio Corp.
Organic Acids Profile Test Large
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EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Olympus Corporation of the Americas
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt
Medtronic, Inc.
MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418
MEDLINE INDUSTRIES, LP - Northfield
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Intersurgical Inc
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Numed Inc
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3
MEDLINE INDUSTRIES, LP - Northfield
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Produc
DJO, LLC
BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
CareFusion 303, Inc.
Allergy Test IgE
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Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mi
Siemens Healthcare Diagnostics, Inc.
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Datascope Corporation
Allergy test Small
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Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:
Zimmer, Inc.
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Articl
B Braun Medical Inc
Apo B Reagent, REF: OSR6143
Beckman Coulter Ireland, Inc.
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been c
Flower Orthopedics Corporation
L12-5 38mm Transducer Probe
Philips Ultrasound, Inc
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Instrumentation Laboratory
Burlington Medical, Wrap Aprons.
Burlington Medical, LLC
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light
Olympus Corporation of the Americas
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Cytocell Ltd.
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