Medical Device Recalls

ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pum

Abiomed, Inc.

DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01

DeRoyal Industries Inc

regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit

ROi CPS LLC

Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications dur

Howmedica Osteonics Corp.

PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.

Stradis Healthcare

Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.

Philips North America

MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polyd

Mentor Texas, LP.

DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02

DeRoyal Industries Inc

CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators

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

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24,

Smiths Medical ASD Inc.

1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S

Synthes (USA) Products LLC

8mm FlexDex Needle Driver, Product Code FD-335 ND

FlexDex Inc.

Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.

Technomed Europe

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Windstone Medical Packaging, Inc.

Achieva XR. Model (REF) Numbers 781153, 781253.

Philips North America

Carefusion V. Mueller CUSHING BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 7" (180MM), REF F-2002

Carefusion 2200 Inc

Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 71

LeMaitre Vascular, Inc.

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open

Smith & Nephew, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000711;

Beaver Visitec International, Inc.

DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09

DeRoyal Industries Inc

PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System

VANTIVE US HEALTHCARE LLC

WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inte

Boston Scientific Corporation

Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L

Medline Industries, LP

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155

TELEFLEX LLC

CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE

Aizu Olympus Co., Ltd.

Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G

MEDLINE INDUSTRIES, LP - Northfield

Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number

Siemens Medical Solutions USA, Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;

Beaver Visitec International, Inc.

restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for

Conformis Inc.

Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version

Encore Medical, LP