Medical Device Recalls

DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.

AVID Medical, Inc.

Braun Thermoscan¿ PRO 6000 Ear Thermometer

Baxter Healthcare Corporation

Flamingo Funnel Small, Model Number SQ20012-01

SurgiSmoke Solutions

Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic,

Philips North America Llc

Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17

American Contract Systems Inc.

ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated

Zimmer, Inc.

Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare

INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)

Abbott Vascular

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050

TELEFLEX LLC

Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Pr

Fujirebio Diagnostics, Inc.

ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomogra

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a

Abbott Molecular, Inc.

regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit

ROi CPS LLC

Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.

Medline Industries, LP

Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063

Leica Microsystems, Inc.

Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE ST

Medtronic Vascular, Inc.

CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with hea

CardioQuip, LLC

NEO DELTA Self Safe, I.V. Catheter REF 3738222

Delta Med SpA

Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conduc

Integra LifeSciences Corp. (NeuroSciences)

YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

Surgical Innovations Ltd

Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

NOX MEDICAL

a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model

Mckesson Medical-Surgical Inc. Corporate Office

Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)

Becton Dickinson & Company

Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

Getinge Disinfection Ab

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

728327 Ingenuity CT Upgrades-Computed Tomography X-ray system

Philips North America Llc

Hamilton-MR1, REF: 161010, Intensive Care Ventilator

Hamilton Medical, Inc.

Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 6362

Microtek Medical Inc.

Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603

Western/Scott Fetzer Company