Medical Device Recalls

Intera 1.5T, Magnetic Resonance System.

Philips North America Llc

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe

Philips North America

QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

Qiagen Sciences LLC

Artelon FlexBand Dynamic Matrix Ref: 31057

International Life Sciences

Model Number 40KWFXPLUS.004, Mobile X-ray system

SEDECAL SA

Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arteri

B Braun Medical Inc

Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hoo

I.T.S. GmbH

Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous

ZOLL Circulation, Inc.

Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DY

MEDLINE INDUSTRIES, LP - Northfield

Hobbs Posi-Stop Injection Needle Catalog Number: 4722

Hobbs Medical, Inc.

Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

Medline Industries, LP

American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item

American Contract Systems Inc

RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures o

Synthes (USA) Products LLC

Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampli

Oridion Medical 1987 Ltd.

HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10

Johnson & Johnson Surgical Vision, Inc.

Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;

Adept Medical Ltd

Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syr

Jiangsu Shenli Medical Production Co., Ltd.

Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compo

Medtronic, Inc.

DeRoyal KIT EXTREMITY PACK, REF 89-8869.09

DeRoyal Industries Inc

Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005

Stryker Corporation

Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08

AVID Medical, Inc.

MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

Mazor Robotics Ltd

SmartPath to dStream for 3.0T, Model Number: 782145;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Synapse PACS - Version 7.1.000

FUJIFILM Healthcare Americas Corporation

BiPAP V30 Auto Ventilator, Part Number 1111178

Philips Respironics, Inc.

Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180

C.R. Bard Inc

Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's

Clark Laboratories, Inc.

VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem

Biomerieux Inc

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, M

MEDLINE INDUSTRIES, LP - Northfield

ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348

Biomerieux Inc