Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,600 total recalls
Tandem Mobi Insulin Pump with Interoperable Technology
Tandem Diabetes Care, Inc.
Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
MEDLINE INDUSTRIES, LP - Northfield
Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON
Medtronic Sofamor Danek USA Inc
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
DePuy Mitek, Inc., a Johnson & Johnson Co.
AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste
Boston Scientific Corporation
Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25600QS
Medline Industries, LP
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of O
Boston Scientific Corporation
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe
Medline Industries, LP
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part
Abiomed, Inc.
Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X
Orthofix U.S. LLC
PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32P
Permobil
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Remel Europe Ltd.
Model Number 40KWFX, Mobile X-ray system
SEDECAL SA
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Breg Inc
Olympus Bronchovideoscope, Models BF-XT190.
Olympus Corporation of the Americas
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Boston Scientific Corporation
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35m
Folsom Metal Products, Inc.
UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeut
UFSK - International OSYS Gmbh
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Numbe
MEDLINE INDUSTRIES, LP - Northfield
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: E
Koven Technology, Inc.
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
CareFusion 303, Inc.
Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
GOLD STAR DISTRIBUTION INC
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C
DeRoyal Industries Inc
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Maquet Cardiopulmonary Gmbh
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS,
Medline Industries, LP
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Des
Thoratec LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780050
TELEFLEX LLC
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Penner Patient Care, Inc.
Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
Stanbio Laboratory, LP
TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE
Full Vision Inc
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