Medical Device Recalls

SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S

PATH

Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics

Ellex Medical Pty Ltd.

Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 8

Encore Medical, LP

myQA iON; Article Number: MQ10-000;

IBA Dosimetry GmbH

LABOR & DELIVERY PACK, Model Nos LLLD19H

American Contract Systems Inc

Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparos

Canadian Hospital Specialties Ltd.

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04

Advance Medical Designs, Inc.

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

Zimmer Surgical Inc

SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-60

Hologic, Inc

X7-2 Transducer Probe

Philips Ultrasound, Inc

KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE

Karl Storz Endoscopy

Centurion FMS Pak

Alcon Research, LTD.

Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVEL

Medline Industries, LP

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Abbott Molecular, Inc.

1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

New Standard Device Inc

EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR

MicroPort Orthopedics Inc.

Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand nam

Collagen Matrix Inc

MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the va

Angiodynamics, Inc.

Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

Cook Biotech, Inc.

Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b

MEDLINE INDUSTRIES, LP - Northfield

Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 Ap

Insulet Corporation

Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;

Philips North America Llc

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15

Linkbio Corp.

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

Siemens Healthcare Diagnostics, Inc.

RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030

TELEFLEX LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001712;

Beaver Visitec International, Inc.

ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators

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

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Edwards Lifesciences, LLC

SynchroMed II Infusion Pump. Product Number: 8637-20

Medtronic Neuromodulation

MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device

Medacta Usa Inc