Medical Device Recalls

Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as

Boston Scientific Corporation

LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026

Physio-Control, Inc.

GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401C

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890

Stradis Medical, LLC dba Stradis Healthcare

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL

Cardinal Health

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus

Merit Medical Systems, Inc.

Centurion STERILE #16 RUBBER BAND, Product Code EB16

MEDLINE INDUSTRIES, LP - Northfield

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

Smiths Medical ASD Inc.

Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps a

MicroSurgical Technology Inc

Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015

Stryker Corporation

Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DEL

American Contract Systems Inc.

OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneL

Novapproach Spine LLC

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060

TELEFLEX LLC

OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System

VANTIVE US HEALTHCARE LLC

Philips S5-1 Transducer.

Philips Ultrasound, Inc

EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M005

Boston Scientific Corporation

Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

Randox Laboratories Ltd.

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Fresenius Medical Care Holdings, Inc.

TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65

TriMed Inc.

Puritan Bennett 980 Series Ventilator, 980X1ENNISB

Covidien Llc

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and

RAYSEARCH LABORATORIES AB

DeRoyal KIT TOTAL HIP, REF 89-8861.07

DeRoyal Industries Inc

Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

Biomet, Inc.

MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R

MEDLINE INDUSTRIES, LP - Northfield

Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indi

Outset Medical, Inc.

Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Ver

Aesculap Inc

Allura Xper series

Philips Medical Systems Nederland B.V.

Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300

C.R. Bard Inc

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POIN

Medline Industries, LP