Medical Device Recalls

WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for

Boston Scientific Corporation

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

B Braun Medical Inc

Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only

Medtronic Vascular, Inc.

regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit

ROi CPS LLC

Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number:

United Orthopedic Corp.

LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52

Linkbio Corp.

MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A

MEDLINE INDUSTRIES, LP - Northfield

Optima XR646 HD. X-Ray imaging system.

GE Medical Systems, LLC

Inactivated macrolide and quinolone-resistant Mycoplasma genitalium

Microbiologics Inc

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.

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

Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2

Pride Mobility Products Corp.

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