Medical Device Recalls

Exactech Ergo Impactor Handle, Catalog #321-09-05.

Exactech, Inc.

API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identifica

Biomerieux Inc

Medtronic InterStim Ground Pad REF 041826

Medtronic Neuromodulation

Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes

Baxter Healthcare Corporation

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 S

Inspire Medical Systems Inc.

L15-7io Transducer Probe

Philips Ultrasound, Inc

Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Steri

Jiangsu Shenli Medical Production Co., Ltd.

BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9

CareFusion 303, Inc.

CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST

Carefusion 2200 Inc

GEM Premier 5000 PAK; Part No. 00055407510.

Instrumentation Laboratory

Navik 3D v2, REF NAVIK3D, 3D Mapping System

APN Health LLC

BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and

Becton Dickinson & Co.

Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 M

Trinity Sterile, Inc.

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Smith & Nephew, Inc.

CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A

MEDLINE INDUSTRIES, LP - Northfield

QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intende

Qiagen GmbH

TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A

American Contract Systems Inc

MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW

MEDLINE INDUSTRIES, LP - Northfield

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack N

MEDLINE INDUSTRIES, LP - Northfield

PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849

Biomerieux Inc

QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO

Maquet Medical Systems USA

1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3.

Thoratec Corp.

DeRoyal CATARACT PACK, REF 89-9241.03

DeRoyal Industries Inc

CareLink Clinic, REF: MMT-7350

Medtronic MiniMed, Inc.

NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog N

Illumina, Inc.

IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm

ICU Medical, Inc.

Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered

SURGIFY MEDICAL OY

STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants dur

Synthes (USA) Products LLC

Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.

AVID Medical, Inc.

Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611

Biomet, Inc.