Medical Device Recalls

Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿

Thoratec LLC

AirTouch N20 Nasal Mask and User Guide

ResMed Ltd.

Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisf

Wright Medical Technology, Inc.

AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Ty

Fresenius Medical Care Holdings, Inc.

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172

Intuitive Surgical, Inc.

ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thromb

Inari Medical - Oak Canyon

DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD

Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB102

Blue Belt Technologies, Inc

DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemo

Angiodynamics, Inc.

Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straum

Preat Corp

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

Olympus Corporation of the Americas

THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-

B. Braun Medical, Inc.

RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.

Aesculap Implant Systems LLC

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04

DeRoyal Industries Inc

SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Mo

ImaCor Inc.

Paracentesis Thoracente, SLPT76H; Medical convenience kit

American Contract Systems, Inc.

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb

Medline Industries, LP

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44

MEDLINE INDUSTRIES, LP - Northfield

DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.

Aesculap Inc

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Nu

Ortho-Clinical Diagnostics, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000921;

Beaver Visitec International, Inc.

CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba

Datascope Corp.

GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.

GE Medical Systems China Co., Ltd.

HYDRATOME RX 44-20MM/260CM Material Number: M00583040

Boston Scientific Corporation

Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK

Medline Industries, LP

GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2

GE Healthcare

Achieva 3.0T, Model No. 781177

Philips North America

SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

PATH

Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.