Medical Device Recalls

Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used i

Preat Corp

Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.

Stryker GmbH

Synapse PACS - Version 7.3.000

FUJIFILM Healthcare Americas Corporation

Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

Philips North America Llc

The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ

LeMaitre Vascular, Inc.

Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

Windstone Medical Packaging, Inc.

DeRoyal SHOULDER PACK, REF 89-9449.12

DeRoyal Industries Inc

Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is a

Respironics California, LLC

Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary

Flower Orthopedics Corporation

Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode

Megadyne Medical Products, Inc.

Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979

Stryker Spine

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter

Boston Scientific Corporation

Lyme Test

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COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator

Medtronic Inc.

Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF

Carefusion 2200 Inc

ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB 40CT, SKU 906023

Family Dollar Stores, Llc.

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

Fresenius Kabi USA, LLC

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

Smiths Medical ASD Inc.

Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall

Cardinal Health 200, LLC

DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09

DeRoyal Industries Inc

Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated

Fresenius Kabi USA, LLC

Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOT

MEDLINE INDUSTRIES, LP - Northfield

Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF D

MEDLINE INDUSTRIES, LP - Northfield

Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pi

Boston Scientific Corporation

Arjo Disposable Repositioning Sling, Model AHD001

Getinge Dominican Republic SA

Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339

MEDLINE INDUSTRIES, LP - Northfield

CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL LENGTH 7-1/2" (190MM) , REF F-1000

Carefusion 2200 Inc

3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 I

3M Company - Health Care Business