Medical Device Recalls

LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2

Hill-Rom, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter

Boston Scientific Corporation

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

DEPUY (IRELAND)

HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,

Stradis Medical, LLC dba Stradis Healthcare

MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

Philips North America Llc

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number D

MEDLINE INDUSTRIES, LP - Northfield

Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

Covidien

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

Boston Scientific Corporation

Regard, T AND A - Rogers, sterilized convenience kits

ROi CPS LLC

CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit

Caire, Inc.

Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump

ARROW INTERNATIONAL Inc.

Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Numb

Mckesson Medical-Surgical Inc. Corporate Office

Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS

Medline Industries, LP

COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; R

Cook Incorporated

Access Total T4, REF 33800, IVD, thyroxine reagent assay.

Beckman Coulter, Inc.

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13

Linkbio Corp.

OptiCross Coronary Imaging Catheter, REF H749518080120

Boston Scientific Corporation

RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.

Encore Medical, LP

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

Fresenius Medical Care Holdings, Inc.

Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B;

MEDLINE INDUSTRIES, LP - Northfield

CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators

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

VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and ro

Steris Corporation

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

CORNEAT VISION, LTD.

Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Pro

Olympus Corporation of the Americas

IntelliVue Patient Monitor MX500. Model Number: 866064

Philips North America Llc

BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to th

RONAN MEDICAL LLC

Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001

Medtronic Perfusion Systems

Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lu

Edwards Lifesciences, LLC

GEM Premier 5000; Part No. 00055445008.

Instrumentation Laboratory