Medical Device Recalls

c5-1 Transducer Probe

Philips Ultrasound, Inc

DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

Beckman Coulter, Inc.

Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, P

MEDLINE INDUSTRIES, LP - Northfield

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

Beckman Coulter, Inc.

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232

Cardinal Health 200, LLC

JAGTOME RX 39-30-450-025 Material Number: M00573110

Boston Scientific Corporation

Evolution Upgrade 3.0T, Magnetic Resonance System.

Philips North America Llc

TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patien

Tytek Medical Inc

Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in no

BearCare, Inc.

CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5018

Carefusion 2200 Inc

Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F

Medline Industries, LP

Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001

Align Technology Inc

Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-003

Exactech, Inc.

Achieva 1.5T Initial System

Philips North America Llc

3T Heater Cooler System, REF: 16-02-85

LivaNova Deutschland GmbH

RAPIDPOINT 500e Blood Gas System

Siemens Healthcare Diagnostics Inc

Access Thyroglobulin Calibrators

Beckman Coulter, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter

Boston Scientific Corporation

Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB

AURIS HEALTH INC

TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

Johnson & Johnson Surgical Vision, Inc.

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125

TELEFLEX LLC

Change Healthcare Cardiology Hemodynamics software

A L I Technologies Ltd

Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03

AVID Medical, Inc.

Model Number L110, ESSENTIO SR SL MRI Pacemaker

Boston Scientific Corporation

Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003

Medline Industries, LP

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040

TELEFLEX LLC

Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840

Western/Scott Fetzer Company

Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE

Medline Industries, LP

BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8

Becton Dickinson & Company

Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR

Jiangsu Shenli Medical Production Co., Ltd.