Medical Device Recalls

Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3S

Carefusion 2200 Inc

Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only

Cepheid

Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

GE Healthcare, LLC

Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

Adept Medical Ltd

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ

Exactech, Inc.

STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qual

SD Biosensor, Inc.

Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VL

Covidien, LP

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an int

Boston Scientific Corporation

ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indic

Zimmer, Inc.

DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01

Biomerieux Inc

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L

Smiths Medical ASD Inc.

ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loo

Olympus Corporation of the Americas

BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; a

Bio-Rad Laboratories, Inc.

Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra

Integra LifeSciences Corp.

True 3D Viewer, Model: EP-00003

Echopixel, Inc.

Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance

Becton, Dickinson and Company, BD Bio Sciences

Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / Q

Baxter Healthcare Corporation

Shimadzu, Trinias, Digital Angiography System

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number

Zimmer, Inc.

Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

Medtronic Neuromodulation

NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifo

Medline Industries Inc

Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

Medline Industries, LP

RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025

TELEFLEX LLC

Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DV

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

Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software

Philips Medical Systems (Cleveland) Inc

SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in

Integra LifeSciences Corp.

MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY,

MEDLINE INDUSTRIES, LP - Northfield

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E

American Contract Systems Inc

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerot

Arrow International Inc