RecallHawk

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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