Medical Device Recalls

HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of

Boston Scientific Corporation

Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for pr

Olympus Corporation of the Americas

Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not

ARROW INTERNATIONAL Inc.

BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9

CareFusion 303, Inc.

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump

ARROW INTERNATIONAL Inc.

Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449

Baxter Healthcare Corporation

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

Howmedica Osteonics Corp.

Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-4

Cook Incorporated

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/

Angiodynamics, Inc.

HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

O&M HALYARD, INC.

Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312

DePuy Orthopaedics, Inc.

Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025

Beaver Visitec International, Inc.

ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A

Medline Industries, LP

C5-2 Lumify Transducer Probe

Philips Ultrasound, Inc

ProCuity bed series, model number 3009, item number: 3009PX-LE-400.

Stryker Medical Division of Stryker Corporation

Spectrum IQ Infusion Pump, Product Code 3570009

Baxter Healthcare Corporation

Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

Hobbs Medical, Inc.

MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

Illumina, Inc.

CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and Ind

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capa

ZOLL Circulation, Inc.

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

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