Medical Device Recalls

Philips C9-4 Ultrasound Transducer

Philips Ultrasound, Inc

WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal

Boston Scientific Corporation

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis

Baxter Healthcare Corporation

FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure mo

Edwards Lifesciences, LLC

Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

Beckman Coulter, Inc.

ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL

Mckesson Medical-Surgical Inc. Corporate Office

Intera 0.5T Standard, Magnetic Resonance System.

Philips North America Llc

REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery P

W L Gore & Associates, Inc.

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Produ

Angiodynamics, Inc.

Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120

C.R. Bard Inc

2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside

Bunnell, Inc.

PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13

Aesculap Implant Systems LLC

Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE

Busse Hospital Disposables, Inc.

AMX Navigate Mobile X-Ray System

GE Healthcare, LLC

Plus Initial Drill, Article Number: 103.170;

Straumann USA LLC

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP AC

Medline Industries, LP

Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant war

GE Medical Systems, LLC

Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A

Philips North America LLC

Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW

Vapotherm

Allura Xper FD20 OR Table; Model Number: 722023;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product Description: NON-Sterile

Jiangsu Shenli Medical Production Co., Ltd.

SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

Fresenius Medical Care Holdings, Inc.

GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic re

GE Healthcare, LLC

Cardiac Workstation 7000; Model Number: 860441;

Philips North America

stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bon

Stryker GmbH

VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217

Biomerieux Inc

Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

Siemens Healthcare Diagnostics, Inc.

In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742

BioFire Diagnostics, LLC