Medical Device Recalls

CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 20786

GE Healthcare Finland Oy

Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;

Philips North America

GEM Premier 5000 PAK; Part No. 00055407508.

Instrumentation Laboratory

ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap,

ICU Medical, Inc.

BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141

CAREFUSION

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/

Baxter Healthcare Corporation

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole bl

Accriva Diagnostics, Inc.

Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system

SEDECAL SA

Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D

MEDLINE INDUSTRIES, LP - Northfield

Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including di

Steris Corporation

"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351

Busse Hospital Disposables, Inc.

Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400

Cardinal Health 200, LLC

HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL

O&M HALYARD INC

GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.

HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

Access Vascular, Inc

The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algo

SIGHT DIAGNOSTICS LTD

VentStar Watertrap (N) 180, MP00363

Draeger Medical, Inc.

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.

Olympus Corporation of the Americas

Craftmatic Model 1 Base for Dual Bed Configurations

Craftmatic Industries, Inc.

ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J

ARROW INTERNATIONAL, LLC

PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592

GE Medical Systems Information Technologies Inc

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06

Linkbio Corp.

Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Nu

Stryker Corporation

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-

ZOLL Medical Corporation

Phoenix mKDR Xpress, digital mobile diagnostic x-ray system

SEDECAL SA

Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CI

MEDLINE INDUSTRIES, LP - Northfield

Peptic Ulcer Test (H, pylori)

GET TESTED INTERNATIONAL AB

MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW

Medtronic MiniMed, Inc.

Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

Draeger Medical, Inc.

cobas infinity central lab, Material Number 07154003001

Roche Diagnostics Operations, Inc.