Medical Device Recalls

Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pac

MEDLINE INDUSTRIES, LP - Northfield

GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction

GE Medical Systems Information Technologies Inc

nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring do

Landauer

Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

Diasol, Inc

Tecfen Retractable Membrane Polisher, QTPR1267-23

Vortex Surgical Inc.

ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of p

Boston Scientific Corporation

VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IV

Ventana Medical Systems, Inc.

SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568

Avanos Medical, Inc.

Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system

SEDECAL SA

Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIA

MEDLINE INDUSTRIES, LP - Northfield

Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product De

MICROspecialties, Inc.

ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240

Biomerieux Inc

SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

Philips North America

NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02

Zimmer, Inc.

FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component

Abbott Diabetes Care, Inc.

SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic inten

The Metrix Company

Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P

Baxter Healthcare Corporation

ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

Intera Achieva 1.5T Pulsar; Product Number: 781171;

Philips North America

Molding Equipment. WCM series. Model WCM-330GL-i

Apic Yamada America

Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of th

Abiomed, Inc.

GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.

GE Medical Systems China Co., Ltd.

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis

Baxter Healthcare Corporation

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584545;

Beaver Visitec International, Inc.

Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

Integra LifeSciences Corp.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Patient Information Center iX; Software Version Number: 4.5.0

Philips North America

MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system

GE Medical Systems Information Technologies Inc

Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Ac

Olympus Corporation of the Americas