Medical Device Recalls

Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502

B Braun Medical Inc

RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it

Smith & Nephew Medical, Ltd.

Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

Olympus Corporation of the Americas

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113

Medtronic Perfusion Systems

Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214

Medline Industries, LP

Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of pati

Getinge Usa Sales Inc

FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685

Richard Wolf GmbH

Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number

MEDLINE INDUSTRIES, LP - Northfield

Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

Philips North America

ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.

B. Braun Medical, Inc.

Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anch

Paragon 28, Inc.

REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859

Abbott Laboratories

Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx

Edwards Lifesciences, LLC

BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desk

CareFusion 303, Inc.

Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;

Abiomed, Inc.

MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

Medtronic MiniMed, Inc.

WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

Straumann USA LLC

B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar

B Braun Medical Inc

SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 1

TEI Biosciences, Inc.

Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: D

Medline Industries, LP

Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is a

Abbott Medical

Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915

Ortho-Clinical Diagnostics, Inc.

Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system

Siemens Medical Solutions USA, Inc

Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 M

MEDLINE INDUSTRIES, LP - SPT

SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

Limacorporate S.p.A

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;

Wilson-Cook Medical Inc.

TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928

Full Vision Inc

Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff;

TELEFLEX LLC

Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSO

GE Healthcare, LLC