Medical Device Recalls

Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator

Medtronic Inc.

GE HealthCare OEC 9800.

GE Medical Systems, LLC

Restrata, Part Number RWM1-2X2

Acera Surgical Inc

HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P

HeartSine Technologies Ltd

Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYN

Medline Industries, LP

IntelliVue Patient Monitor MX450. Model Number: 866062

Philips North America Llc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001943;

Beaver Visitec International, Inc.

EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole

IMPLANTCAST GMBH

Ion Endoluminal System, REF: 380748-65

Intuitive Surgical, Inc.

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560

Boston Scientific Corporation

Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Ster

Jiangsu Shenli Medical Production Co., Ltd.

Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1

RAYSEARCH LABORATORIES AB

MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an abs

Ethicon, Inc.

18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;

DAYE (ANNE'S DAY LTD)

CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A

CardioQuip, LLC

Alinity m HBV AMP Kit (US and CE)

Abbott Molecular, Inc.

VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346

Biomerieux Inc

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

B Braun Medical Inc

C-SECTION PACK, Model Nos LLCS44F LLCS44F-01

American Contract Systems Inc

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Baxter Healthcare Corporation

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-5015

CORIN MEDICAL, LTD.

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-

ConMed Corporation

LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40

Linkbio Corp.

HeartWare HVAD Outflow Graft, REF MCS1725OG

Heartware, Inc.

Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Desc

Abbott Diagnostics Scarborough, Inc.

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an i

Stryker Medical Division of Stryker Corporation

GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10

DeRoyal Industries Inc

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0

Smiths Medical ASD, Inc.