Medical Device Recalls

Penner Pacific Bathing Spa, Model Numbers 360020-1P

Penner Patient Care, Inc.

Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP

Medline Industries, LP

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

Philips Medical Systems Nederland B.V.

Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Prod

Olympus Corporation of the Americas

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Nu

Medline Industries, LP

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035

TELEFLEX LLC

MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Med

Medline Industries, LP

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization

Medtronic Sofamor Danek USA Inc

HeartWare HVAD Pump Implant Kit, REF 1125

Heartware, Inc.

BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibr

Bio-Rad Laboratories, Inc.

A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal

Tyber Medical

Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers ar

Cook Incorporated

Philips eL18-4 EMT Transducer.

Philips Ultrasound, Inc

Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S

SPINEART SA

Vitamin D-Test

GET TESTED INTERNATIONAL AB

Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A

Intrinsic Therapeutics, Inc.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMI

Medline Industries, LP

Merlin PCS 3650 programmer Model 3330 software

St. Jude Medical, Cardiac Rhythm Management Division

BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catal

Becton Dickinson & Co.

MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system

SEDECAL SA

Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAS

MEDLINE INDUSTRIES, LP - Northfield

Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pul

GE MEDICAL SYSTEMS, ISRAEL LTD.

SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

Volcano Corporation

Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

C.R. Bard Inc

da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSC

Intuitive Surgical, Inc.

The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEO

Olympus Corporation of the Americas

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RaySta

RAYSEARCH LABORATORIES AB

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

W L Gore & Associates, Inc.

DeRoyal VIT RD PACK 86ST, REF 89-7308.09

DeRoyal Industries Inc

QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No.

Maquet Medical Systems USA