Medical Device Recalls

Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Covidien Llc

Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated ana

Randox Laboratories Ltd.

LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265

Family Dollar Stores, Llc.

GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

DePuy Orthopaedics, Inc.

Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video

SEER MEDICAL PTY LTD

Servo-n Ventilator System. Model Number: 6694800.

Maquet Critical Care AB

C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04

American Contract Systems Inc

Intera 1.5T R11, Magnetic Resonance System.

Philips North America Llc

HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device

MEDLINE INDUSTRIES, LP - Northfield

Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

Philips Healthcare (Suzhou) Co., Ltd.

GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems

GE Healthcare (China) Co., Ltd.

Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULA

Medline Industries, LP

Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD

MEDLINE INDUSTRIES, LP - Northfield

Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

Brainlab AG

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Gri

Olympus Corporation of the Americas

Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,

Stryker Corporation

smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr

Smiths Medical ASD, Inc.

Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP

Bridge to Life Ltd

¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit

ROi CPS LLC

DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09

DeRoyal Industries Inc

Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table

Pivotal Health Solutions, Inc.

X3 TRIATHLON CS INSERT NO 3 10 MM

Howmedica Osteonics Corp.

Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

Xstrahl Limited

Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, P

MEDLINE INDUSTRIES, LP - Northfield

Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Mod

Siemens Medical Solutions USA, Inc

QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567

Microgenics Corporation

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) S

MEDLINE INDUSTRIES, LP - Northfield

IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restoratio

IVOCLAR VIVADENT AG

Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15

American Contract Systems Inc.

Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL

MEDLINE INDUSTRIES, LP - Northfield