Medical Device Recalls

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC

Olympus Corporation of the Americas

Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-26

Cook Incorporated

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.

Olympus Corporation of the Americas

AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

Boston Scientific Corporation

Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.

Mobius Imaging, LLC

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Produc

Avanos Medical, Inc.

Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L

Paragon 28, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000813;

Beaver Visitec International, Inc.

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

Baxter Healthcare Corporation

MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COM

MEDLINE INDUSTRIES, LP - Northfield

Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.

Stanbio Laboratory, LP

Drug Test Small (4 substances)

GET TESTED INTERNATIONAL AB

REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.

MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery

Megadyne Medical Products, Inc.

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 099

Datascope Corp.

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18

Diversatek Healthcare

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635

Biomet, Inc.

GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-00

GE Healthcare

Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25

Vortex Surgical Inc.

PE Centrifuge, REF: B36365, a component of the Power Express

Beckman Coulter Biomedical GmbH

SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Sy

Philips North America Llc

Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses

Augustine Temperature Management, LLC

RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c)

Teleflex Medical Europe Ltd

Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit

Medical Action Industries, Inc. 306

FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

Inpeco S.A.

1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray

American Contract Systems, Inc.

Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

Ethicon Endo-Surgery Inc

REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery

W L Gore & Associates, Inc.

Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal

Cook Biotech, Inc.

Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.