Medical Device Recalls

VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system c

bioMerieux, Inc.

MPOX Test

GET TESTED INTERNATIONAL AB

FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code

O&M HALYARD, INC.

KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightgua

Keystone Industries

Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR

Jiangsu Shenli Medical Production Co., Ltd.

ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software

Siemens Medical Solutions USA, Inc.

WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-ope

WHILL, INC.

OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic an

GE OEC Medical Systems, Inc

Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000567;

Beaver Visitec International, Inc.

IRON assay, Reference Numbers 6K95-41 and 6K95-30

Sentinel CH SpA

REGARD Core Biopsy Tray

ROi CPS LLC

Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Ca

Zimmer, Inc.

Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

Cook Biotech, Inc.

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716

Hobbs Medical, Inc.

Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU

ARROW INTERNATIONAL, LLC

Olympus Bronchovideoscope, Models BF-MP190F.

Olympus Corporation of the Americas

Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP R

Medline Industries, LP

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180

Olympus Corporation of the Americas

AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680

Boston Scientific Corporation

BD Pyxis MedStation 4000 Main, REF 303

CareFusion 303, Inc.

CS300 IABP. Software Version CS300 IABP C.01.

Datascope Corp.

Allura Xper FD20/20; Model Number: 722038;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion devic

Medicrea International

Achieva 3.0TX for PET, Magnetic Resonance System.

Philips North America Llc

SOMATOM Definition AS with software syngo.CT VB20 Model #8098027

Siemens Medical Solutions USA, Inc

Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-8

Smiths Medical ASD Inc.

Ingenia 1.5T CX

Philips North America Llc

a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANC

Mckesson Medical-Surgical Inc. Corporate Office

1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

GE Healthcare, LLC