Medical Device Recalls

Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy

Angiodynamics, Inc.

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

NeuMoDx Molecular Inc

Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

Boston Scientific Corporation

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medi

3B Medical, Inc.

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Carl Zeiss Meditec, Inc.

BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.

MEDLINE INDUSTRIES, LP - Northfield

PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL1

Pajunk Medical Systems, L.P.

Alphenix INFX-8000V, interventional fluoroscopic x-ray system

Canon Medical System, USA, INC.

Baxter Spectrum IQ Infusion Pump, Product Code 3570009

Baxter Healthcare Corporation

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part

Baxter Healthcare Corporation

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS

Stryker Corporation

Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched dev

Materialise N.V.

ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785

MEDLINE INDUSTRIES, LP - Northfield

CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

GE Medical Systems Information Technologies Inc

Burlington Medical, Caps.

Burlington Medical, LLC

Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer

Baxter Healthcare Corporation

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 888810300

Covidien LP

GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR

Wipro GE Healthcare Private Ltd.

GORE CARDIOFORM ASD Occluder. cardiovascular implant.

W L Gore & Associates, Inc.

DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

Regard brand CABG Pack A and B - Spartanburg

ROi CPS LLC

COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Refer

Cook Incorporated

VIDAS Mumps IgG (MPG), REF 30218

bioMerieux, Inc.

Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer,

CELLTRION USA INC

Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.

DICOM Grid, Inc. d/b/a Ambra Health

Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor

Verathon, Inc.

Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.

Baxter Healthcare Corporation