Medical Device Recalls

The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

Abbott Molecular, Inc.

Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, U

Aizu Olympus Co., Ltd.

ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Pr

Smith & Nephew Inc.

Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the br

Integra LifeSciences Corp.

2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960

Tenderneeds Fertility LLC

Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX P

Medline Industries, LP

ProCuity bed series, model number 3009, item number: 3009PX-L-200

Stryker Medical Division of Stryker Corporation

Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T

Cardinal Health 200, LLC

ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation

Instrumentation Laboratory

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028

Hobbs Medical, Inc.

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508

Howmedica Osteonics Corp.

RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RaySta

RAYSEARCH LABORATORIES AB

For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

Aesculap Implant Systems LLC

Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03

Onkos Surgical, Inc.

VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installa

Steris Corporation

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Elekta Inc

MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

Stryker Leibinger GmbH & Co. KG

BASIN SET, MEBS42K, general surgical kit

American Contract Systems, Inc.

ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with

Onkos Surgical, Inc.

CustomEyes kits

Beaver Visitec International, Inc.

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkins

Medtronic Neuromodulation

SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contai

The Metrix Company

GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.

GE Healthcare, LLC

Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Si

Contamac Solutions, Inc.

Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100

DePuy Orthopaedics, Inc.

Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is

Olympus Corporation of the Americas

Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908

Howmedica Osteonics Corp.

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

Spacelabs Healthcare, Inc.

NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-

Northeast Scientific Inc.