Medical Device Recalls

Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85

Atrium Medical Corporation

EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

Encore Medical, LP

P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107

Howmedica Osteonics Corp.

Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

Allergan Sales, LLC

CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000

Zeltiq Aesthetics, Inc

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

B Braun Medical Inc

ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutte

Ethicon Endo-Surgery Inc

Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAG

MEDLINE INDUSTRIES, LP - Northfield

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001382;

Beaver Visitec International, Inc.

Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis P

Medtronic Neuromodulation

Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusio

Covidien Llc

Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/

Vyaire Medical

Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY

Abbott Medical

SM_40HF_BDC, Mobile X-ray system

SEDECAL SA

Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 P

Integra LifeSciences Corp. (NeuroSciences)

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 13

Exactech, Inc.

IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100

Angiodynamics, Inc.

Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827

MEDLINE INDUSTRIES, LP - Northfield

Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows

Stryker Corporation

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090

TELEFLEX LLC

Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709

Respironics California, LLC

UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cyst

Scholly Fiberoptic Gmbh

SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, c

Coltene Whaledent Inc

2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare

Fresenius Medical Care Holdings, Inc.

Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2

MEDLINE INDUSTRIES, LP - Northfield

OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

SIMPLIVIA HEALTHCARE LTD.

Paradigm REF: MMT-712 and MMT-715

Medtronic MiniMed, Inc.

SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) an

XTANT Medical Holdings, Inc