Medical Device Recalls

Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation d

Deerfield Imaging, Inc.

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP

Covidien LP

BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitorin

CareFusion 303, Inc.

Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar ene

Boston Scientific Corporation

Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid spac

Integra LifeSciences Corp.

Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

Medline Industries, LP

INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Mod

CooperSurgical, Inc.

Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

Bio-Rad Laboratories

ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Cod

Abiomed, Inc.

Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.

AVID Medical, Inc.

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonanc

GE Healthcare, LLC

Impella RP Flex with SmartAssist. Product Code: 1000323.

Abiomed, Inc.

Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile

Jiangsu Shenli Medical Production Co., Ltd.

Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,

Masimo Corporation

One Step K in vitro diagnostic test REF: 81A4

DFI Co., Ltd.

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Gentueri Inc

da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1

Intuitive Surgical, Inc.

17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-O

DRG International, Inc.

Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inte

Abiomed, Inc.

IntelliVue Patient Monitor MX800. Product Number: 865240.

Philips North America Llc

Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150

Mentor Texas, LP.

Spectral CT. Computed tomography X-ray system.

Philips North America Llc

3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A

KCI USA, INC.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.

Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy S

Noah Medical Corporation

Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

Beckman Coulter, Inc.

BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)

Becton Dickinson & Company

EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adult

Olympus Corporation of the Americas

Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS

Medline Industries, LP

Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

ACTIM OY