Medical Device Recalls

Hand Pack, AKHD97C; Medical convenience kit

American Contract Systems, Inc.

Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Produ

Olympus Corporation of the Americas

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RaySta

RAYSEARCH LABORATORIES AB

HIGH V+ Spinal Cement System REF T040321K

TEKNIMED SAS

GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic

GE Healthcare, LLC

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814

BioPro, Inc.

ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)

Synapse PACS - Version 7.2.100

FUJIFILM Healthcare Americas Corporation

Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Sli

Maquet Medical Systems USA

Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

Philips North America Llc

Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

Randox Laboratories Ltd.

EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

Boston Scientific Corporation

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

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.

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch

Exactech, 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.

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.

Philips Respironics, Inc.

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

Medtronic, Inc.