Medical Device Recalls

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

GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems

GE Healthcare (China) Co., Ltd.

Philips Incisive CT

Philips Healthcare (Suzhou) Co., Ltd.

3M Attest Steam Chemical Integrators, REF 1243B

3M Company - Health Care Business

Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568

Busse Hospital Disposables, Inc.

Coapt Dome Electrode, Gen2 system, cutaneous electrode

Coapt LLC

t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

Tandem Diabetes Care, Inc.

Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descripti

Trividia Health, Inc.

MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723

MEDLINE INDUSTRIES, LP - Northfield

Oculus Pentacam AXL , Ref 70100, CE 0123

Oculus Optikgeraete GMBH

stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Inst

Tornier S.A.S.

GE HealthCare OEC 9900 Elite C-arm Systems.

GE Medical Systems, LLC

Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.

Philips North America

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emi

MAX LUX CORP

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, tempe

Midmark Corporation

Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque

Cardinal Health 200, LLC