Medical Device Recalls

iBOT PMD with software version 01.05.24. Personal Mobility Device.

Mobius Mobility LLC

Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" A

Steris Corporation

Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, T

Baxter Healthcare Corporation

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Car

Medtronic Perfusion Systems

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH,

MEDLINE INDUSTRIES, LP - Northfield

CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators

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

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy

Boston Scientific Corporation

IntelliSpace Cardiovascular, Software 8.0.0.4.

Philips Medical Systems Nederland B.V.

HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray

Stradis Medical, LLC dba Stradis Healthcare

Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptoco

Hologic, Inc

MODEL: X-RAY TV SYSTEM SONIALVISION G4

Shimadzu Medical Systems

LOCAL PACK. Sterile Procedural Tray.

MEDLINE INDUSTRIES, LP - Northfield

DeRoyal PEDI ORTHO PACK, REF 89-5323.20

DeRoyal Industries Inc

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190

Olympus Corporation of the Americas

Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A

Alcon Research LLC

Alinity hq Analyzer, REF: 09P68-01

Abbott Laboratories

AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

GE Medical Systems, SCS

MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

Aesculap Implant Systems LLC

CoolSeal Generator, REF: CSL-200-50

Bolder Surgical, LLC

Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF

MEDLINE INDUSTRIES, LP - Northfield

Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate pl

Centerline Biomedical Inc

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Allura Xper IGTS Fixed Systems

Philips North America

Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050,

ETAC A/S

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump

ARROW INTERNATIONAL Inc.

Philips C5-2 Transducer.

Philips Ultrasound, Inc

RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to

Siemens Healthcare Diagnostics Inc

Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient

Megadyne Medical Products, Inc.

Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385

Baxter Healthcare Corporation

Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST

Remel Inc