Medical Device Recalls

Puritan Bennett 980 Series Ventilator, 980X1ENDIUU

Covidien Llc

MiniMed 530G Insulin Pump (MMT-551, MMT-751)

Medtronic MiniMed, Inc.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model

MEDLINE INDUSTRIES, LP - Northfield

GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance

GE Medical Systems, LLC

Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384

Breas Medical, 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

Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm),

IMPERATIVE CARE INC

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.