Medical Device Recalls

Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti

Philips North America Llc

Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1

Draeger Medical Systems, Inc.

CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP

Integra LifeSciences Corp.

Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT10

InfuTronix LLC

LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Mo

Jolife AB

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296

Intuitive Surgical, Inc.

Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in c

Olympus Corporation of the Americas

GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF:

Ventec Life Systems, Inc.

VentStar Bag Set (N) 110, MP00383

Draeger Medical, Inc.

Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Acceler

Inpeco S.A.

Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377

MEDLINE INDUSTRIES, LP - Northfield

Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 In

Cook Inc.

Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100k

Xstrahl Limited

Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile s

Jiangsu Shenli Medical Production Co., Ltd.

Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Descriptio

Olympus Corporation of the Americas

Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model

Maquet Medical Systems USA

Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis

Outset Medical, Inc.

(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU

ASO LLC

NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM

Howmedica Osteonics Corp.

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

Getinge Usa Sales Inc

Medex LOGICAL CATH LAB KIT, List Number M20754

Smiths Medical Asd Inc

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear

GE Healthcare, LLC

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

Medline Industries, LP

Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgica

Straumann USA LLC

EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

Encore Medical, LP

remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containi

Remel, Inc

Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE

Cardinal Health 200, LLC

Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A

Alcon Research LLC