Medical Device Recalls

PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic a

Pentax of America Inc

Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung

Baxter Healthcare Corporation

Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demon

Gibson Bioscience

BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro d

Becton Dickinson & Co.

ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in

Siemens Healthcare Diagnostics, Inc.

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Remel Inc

Various ENT Packs

American Contract Systems, Inc.

30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.

B. Braun Medical, Inc.

Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter

Boston Scientific Corporation

Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM G

Baxter Healthcare Corporation

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactiv

Boston Scientific Corporation

BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

Beckman Coulter, Inc.

Separation Technology Creamatocrit Plus, Catalog Number: 100-146

Stanbio Laboratory, LP

Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777

Cardinal Health 200, LLC

BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3),

Flexicare Medical (Dongguan) Ltd.

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP,

Exactech, Inc.

GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000;

GE Medical Systems China Co., Ltd.

Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal

Draeger Medical, Inc.

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constr

Zimmer, Inc.

Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK

MEDLINE INDUSTRIES, LP - Northfield

Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E EN

Cardinal Health 200, LLC

medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

Smiths Medical ASD, Inc.

Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Fl

Flower Orthopedics Corporation

Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega S

Megadyne Medical Products, Inc.

Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830

MEDLINE INDUSTRIES, LP - Northfield

Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

Philips North America Llc

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

CELLTRION USA INC

NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

Smiths Medical ASD Inc.

AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode

Ad-Tech Medical Instrument Corporation

QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200

Z-Medica, LLC