Medical Device Recalls

CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

Terumo Cardiovascular Systems Corporation

Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chr

AB SCIEX

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interacti

Boston Scientific Corporation

Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion sur

Aesculap Implant Systems LLC

SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use i

Integra LifeSciences Corp.

One Step 10A in vitro diagnostic test

DFI Co., Ltd.

9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous de

Preat Corp

DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF

Delta Med SpA

Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060

Boston Scientific Corporation

3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-06004

Mindray DS USA, Inc. dba Mindray North America

Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160

C.R. Bard Inc

IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients wit

Ion Beam Applications S.A.

Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS

Medline Industries, LP

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List

Smiths Medical ASD Inc.

RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to

Siemens Healthcare Diagnostics Inc

Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from

Dynasthetics LLC

The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chambe

Atrium Medical Corporation

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump

ARROW INTERNATIONAL Inc.

Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03

AVID Medical, Inc.

Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F

Zyno Medical LLC

ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments hold

MEDTECH SAS

Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only

Abbott Medical

MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84

MEDLINE INDUSTRIES, LP - Northfield

ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486

Biomerieux Inc

Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010

Stryker Corporation

ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

Siemens Healthcare Diagnostics, Inc.

Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

MEDLINE INDUSTRIES, LP - Northfield

BD Pyxis MedStation ES, REF: 323

CareFusion 303, Inc.

DigitalDiagnost C50 1.1

Philips North America Llc