Medical Device Recalls

Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2M

Baxter Healthcare Corporation

iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochle

Iotamotion Inc

Allura Xper FD20 Biplane; Model Number: 722008;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106

Philips North America

Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes M

Olympus Corporation of the Americas

One Step Ovulation Test REF 200-01

Universal Meditech Inc.

Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Softwar

Heraeus Medical GmbH (Dental Division)

MiniMed 620G Insulin Pump (O.U.S. version)

Medtronic MiniMed

TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;

Straumann USA LLC

Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner

Covidien

GM Helix Acqua Implant, Article Number: 140.984

Straumann USA LLC

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

Waldemar Link GmbH & Co. KG (Mfg Site)

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Produc

DJO, LLC

Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193,

Baxter Healthcare Corporation

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

B Braun Medical Inc

LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult

Philips Respironics, Inc.

Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015

Stryker Corporation

Standard IUD Insertion Kit

Stradis Medical, LLC dba Stradis Healthcare

AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Syste

Boston Scientific Corporation

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC

Cordis US Corp

Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G;

American Contract Systems, Inc.

Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicat

Helena Laboratories, Corp.

G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177

Thor Photomedicine Ltd

ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators

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

HarmonyAIR A-Series Surgical Lighting System

Steris Corporation

Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEED

MEDLINE INDUSTRIES, LP - Northfield

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035

BioPro, Inc.

ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators

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

GENERAL ROBOTIC PACK. Medical convenience kit.

AVID Medical, Inc.

Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.

Integra LifeSciences Corp. (NeuroSciences)