Medical Device Recalls

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

Baxter Healthcare Corporation

Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.

RAYSEARCH LABORATORIES AB

Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; C

Covidien Llc

Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.

Stryker GmbH

MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-014

REPLIGEN CORPORATION

Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG

Rocket Medical Plc

Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions an

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01

AVID Medical, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter

Boston Scientific Corporation

NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.

Fresenius Medical Care Holdings, Inc.

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310

Biomet, Inc.

WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal

Boston Scientific Corporation

IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the app

Icecure Medical Ltd

Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd

Navajo Manufacturing Company

Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Ma

GE Medical Systems, LLC

CK MB Calibrator, Catalogue Number CK2393

Randox Laboratories Ltd.

DeRoyal CATARACT PACK, REF 89-8650.10

DeRoyal Industries Inc

Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 1

LEICA BIOSYSTEMS NUSSLOCH GMBH

Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile s

Jiangsu Shenli Medical Production Co., Ltd.

Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Sma

Intuitive Surgical, Inc.

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Pr

Avanos Medical, Inc.

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive

Boston Scientific Corporation

Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCE

MEDLINE INDUSTRIES, LP - Northfield

Soltive Premium SuperPulsed Laser System, Model TFL-PLS

Olympus Corporation of the Americas

Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only

Merit Medical Systems, Inc.

Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c)

Medtronic Sofamor Danek USA Inc

MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A

Medline Industries, LP

Philips XL14-3 Transducer.

Philips Ultrasound, Inc

Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

Preat Corp

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three w

Edan Diagnostics