Medical Device Recalls

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.

Olympus Corporation of the Americas

PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

Baxter Healthcare Corporation

Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size

DSAART LLC

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 888810300

Covidien LP

Detector H. Pylori, Catalog Number IHP-30

Immunostics, Inc.

Philips Respironics Amara View Minimal Contact Full-Face Mask

Philips Respironics, Inc.

Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035

Medline Industries, LP

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an

Boston Scientific Corporation

Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number

Boston Scientific Corporation

Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software

Olympus Corporation of the Americas

Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 5

Safeguard US Operating LLC

Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)

Kinsman Enterprises Inc

Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Elec

Boston Scientific Neuromodulation Corporation

Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol

Siemens Healthcare Diagnostics, Inc.

Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

Fenwal Inc

OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defect

Biomet, Inc.

ROBOTIC URO/GYN PACK. Medical convenience kit.

AVID Medical, Inc.

BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatmen

Becton Dickinson & Company

Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

Stryker Orthopaedics

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001314;

Beaver Visitec International, Inc.

Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

ICU Medical, Inc.

Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01

AVID Medical, Inc.

CD11b APC: ASR, REF: 340936, and CE, REF: 333143

Becton, Dickinson and Company, BD Biosciences

Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments

Straumann USA LLC

Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03

AVID Medical, Inc.

Vortex Surgical I2 Injection Kit, VS0500

Vortex Surgical Inc.

Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019

ORTOMA AB

Artis Q floor, Model Number 10848280

Siemens Medical Solutions USA, Inc

ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

ICU Medical, Inc.