Medical Device Recalls

Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE

Medtronic Vascular, Inc.

9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01

ENDO Pharmaceuticals Solutions, Inc.

In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

BioFire Diagnostics, LLC

Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0

Cook Incorporated

MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)

Medtronic MiniMed, Inc.

Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Mo

Steris Corporation

Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip

Olympus Corporation of the Americas

TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization

Synthes (USA) Products LLC

Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088

Medline Industries, LP

OEC Elite Systems with 9-inch Image Intensifier

GE OEC Medical Systems, Inc

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631

Biomet, Inc.

Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxia

Medtronic Inc

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) a

Instrumentation Laboratory

da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874

Intuitive Surgical, Inc.

Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109

Medline Industries, LP

Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expa

Baxter Healthcare Corporation

BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural lig

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

Proxima Drape labeled as FACE LIFT. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape

3M Healthcare Business

Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYN

MEDLINE INDUSTRIES, LP - Northfield

binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoe

Binx Health, Inc.

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019

Medline Industries, LP

Achieva 3.0T TX for PET Model Number (REF): 781479

Philips North America Llc

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100

TELEFLEX LLC

Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HI

American Contract Systems, Inc.

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained

Zimmer, Inc.

C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 prod

Microtek Medical Inc.

Philips IntelliSpace Cardiovascular software, Model 830089.

Philips Medical Systems Nederland B.V.

One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g T

Home Health US, Incorporated

GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA

GE Vingmed Ultrasound As