Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,640 total recalls
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Centinel Spine, Inc.
Colonoscope, Model Number PCF-H190DL.
Olympus Corporation of the Americas
KY JELLY LUBRICANT 2 FL OZ, SKU 901443
Family Dollar Stores, Llc.
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl
Stryker Orthopaedics
25-LHP-928, HeNe Laser System, 25 mW
PACIFIC LASERTECH, LLC
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Imp
Abiomed, Inc.
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Encore Medical, LP
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2
MEDLINE INDUSTRIES, LP - Northfield
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Medtronic MiniMed, Inc.
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery P
W L Gore & Associates, Inc.
Illegally Marketed
GET TESTED INTERNATIONAL AB
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
MEDLINE INDUSTRIES, LP - Northfield
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Cardinal Health 200, LLC
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa
B Braun Medical Inc
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus
Steris Corporation
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM
Covidien, LP
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the
Ortho-Clinical Diagnostics, Inc.
HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
Stradis Medical, LLC dba Stradis Healthcare
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055
TELEFLEX LLC
DeRoyal KIT HEART B PACK, REF 89-9042.07
DeRoyal Industries Inc
Multichem P, Part Code 08P90-10
TECHNO-PATH MANUFACTURING LTD.
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
GE Medical Systems China Co., Ltd.
NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
NovaSignal Corp.
Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
MEDLINE INDUSTRIES, LP - Northfield
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
Boston Scientific Corporation
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007;
Medline Industries, LP
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
Boston Scientific Corporation
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
CardioQuip, LLC
Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED
MEDLINE INDUSTRIES, LP - Northfield
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