Medical Device Recalls

Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model

Checkpoint Surgical Inc

UroPass Ureteral Access Sheaths, 5 pieces/box

Olympus Corporation of the Americas

IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration

IVOCLAR VIVADENT AG

Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914

Cook Incorporated

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222),

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580

TELEFLEX LLC

S. Typhi/Para Typhi A Antigen

Changchun Wancheng Bio-Electron Co., Ltd.

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354

Biomet, Inc.

Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

C.R. Bard Inc

Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

Cell Marque Corporation

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001568;

Beaver Visitec International, Inc.

QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK uni

Microbiologics Inc

Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX

Radiometer Medical ApS

CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US

Graphic Controls Acquisition Corporation

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTR

MEDLINE INDUSTRIES, LP - Northfield

DeRoyal Tonsillectomy Tray, REF 89-10698.01

DeRoyal Industries Inc

NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

Preat Corp

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530

TELEFLEX LLC

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B

RAYSEARCH LABORATORIES AB

Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 4019

MEDLINE INDUSTRIES, LP - Northfield

HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001

Access Vascular, Inc

DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H7871030

Merit Medical Systems, Inc.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.

Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only

Merit Medical Systems, Inc.

Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

Olympus Corporation of the Americas

HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,

Stradis Medical, LLC dba Stradis Healthcare

MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta

Datascope Corp.

Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry S

Keystone Industries

LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

LumiraDx

COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Pa

Cook Incorporated