Medical Device Recalls

Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Naviga

SEASPINE ORTHOPEDICS CORPORATION

Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098

MEDLINE INDUSTRIES, LP - Northfield

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

Ortho-Clinical Diagnostics, Inc.

Allwell Angioplasty Pack REF: IS-30-B1/B

Merit Medical Systems, Inc.

IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;

Angiodynamics, Inc.

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE

Cordis US Corp

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List N

Smiths Medical ASD Inc.

VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793

Ortho-Clinical Diagnostics, Inc

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/S

Medline Industries, LP

Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B

Medline Industries, LP

KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxD

Pro-Dex Inc

Model Number L210 PROPONENT SR SL Pacemaker

Boston Scientific Corporation

Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use

Olympus Corporation of the Americas

One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

Intersurgical Inc

Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.

MEDLINE INDUSTRIES, LP - Northfield

SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging proc

Surgical Theater Inc

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

MEDLINE INDUSTRIES, LP - Northfield

Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010

Aesculap Implant Systems LLC

Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

SEDECAL SA

A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

Medtronic Neuromodulation

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382050

TELEFLEX LLC

MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CD

Medline Industries, LP

Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit n

American Contract Systems, Inc.

Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Sta

C.R. Bard Inc

LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

LSL Healthcare Inc.

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, M

Medline Industries, LP

Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.

Intuitive Surgical, Inc.

Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Cordis US Corp

MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the

Angiodynamics, Inc.