Medical Device Recalls

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695)

Cook Incorporated

Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer

Baxter Healthcare Corporation

IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

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

AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-

Exactech, Inc.

Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC

CarePoint 60 mL Syringe Without Needle, REF: 04-7560

Allison Medical, Inc.

Thermalon Sinus Compress (French), Item Number 24332F

Bruder Healthcare Company, LLC

EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.

Encore Medical, LP

Various convenience packs

American Contract Systems, Inc.

Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Cr

Medtronic, Inc.

ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28

Smiths Medical ASD Inc.

GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia Syste

GE Healthcare, LLC

DBB-06 Hemodialysis Delivery System

Nikkiso Ltd - Shizuoka Plant

REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransfe

Abbott Laboratories

Product Name: Ingenia 1.5T CX; Model Number: 781262;

Philips North America Llc

Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

Ossur H / F

Allura Xper FD10; Model Number: 722003;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834

Randox Laboratories Ltd.

BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

OMNI II TEE Transducer Probe

Philips Ultrasound, Inc

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product

Smiths Medical ASD Inc.

Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;

Philips North America Llc

Description/REF: ACCESS TRAY/ASK-04001-MC3

ARROW INTERNATIONAL, LLC

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b

GE Healthcare

TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fu

Innovasis, Inc

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

Volcano Corp

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000603;

Beaver Visitec International, Inc.

Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS

Philips North America LLC