Medical Device Recalls

Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;

MEDLINE INDUSTRIES, LP - Northfield

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Nu

MEDLINE INDUSTRIES, LP - Northfield

Allia IGS 3 Pulse angiographic X-ray system

GE Medical Systems, LLC

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

Medline Industries, LP

Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;

PHILIPS MEDICAL SYSTEMS

GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPA

MEDLINE INDUSTRIES, LP - Northfield

Non-ablative Fractional Laser Systems, Model: WFB-01

WINGDERM ELECTRO-OPTICS LTD.

Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

Maquet Cardiovascular, LLC

AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740

Boston Scientific Corporation

Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

Diversatek Healthcare

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH4

American Contract Systems Inc

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

Cepheid

React Health PHOENIX 5L Oxygen Concentrator

3B Medical, Inc.

Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

Alere San Diego, Inc.

Medtronic, Simplera Sensor, REF: MMT-5100JD1

Medtronic MiniMed, Inc.

TRACH KIT W/HYDROGEN & SALI

Cardinal Health 200, LLC

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ

MEDLINE INDUSTRIES, LP - Northfield

Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714

Young Dental Manufacturing I, LLC

Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79

SEASPINE ORTHOPEDICS CORPORATION

Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.

Maquet Cardiovascular, LLC

Sensis Vibe Hemo

Siemens Medical Solutions USA, Inc

Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated an

Siemens Healthcare Diagnostics, Inc.

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic

GE Healthcare, LLC

Puritan Bennett 980 Series Ventilator, 980X2ESDIEC

Covidien Llc

CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FO

Smiths Medical ASD, Inc.

Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A

Medline Industries, LP

TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF

American Contract Systems Inc

Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Numbe

Integra LifeSciences Corp.

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy S

Elekta, Inc.