Medical Device Recalls

Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive su

Beaver Visitec International, Inc.

YelloPort Elite Universal Seal. For use in laparoscopic procedures.

Surgical Innovations Ltd

FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for g

FUJIFILM Healthcare Americas Corporation

Snapshot NIR, REF: KD204

KENT IMAGING, INC.

Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be

Flower Orthopedics Corporation

Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Num

Siemens Medical Solutions USA, Inc

ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-

Abiomed, Inc.

VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3

Ortho-Clinical Diagnostics, Inc.

POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur

Olympus Corporation of the Americas

Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)

Dexcom, Inc.

Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)

Medtronic Perfusion Systems

Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, M

Cosmedent, Inc.

Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY

Datex-Ohmeda, Inc.

Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer

Medline Industries, LP

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant

Medtronic Sofamor Danek USA Inc

WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal

Boston Scientific Corporation

Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1

MEDLINE INDUSTRIES, LP - Northfield

CT DAVINCI. Medical convenience kit.

AVID Medical, Inc.

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

Onkos Surgical, Inc.

Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemosta

Wilson-Cook Medical Inc.

BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278

Mckesson Medical-Surgical Inc. Corporate Office

ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-30

Abiomed, Inc.

IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.

Siemens Healthcare Diagnostics, Inc.

LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.

Aesculap Implant Systems LLC

FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Various Laparoscopy Packs

American Contract Systems, Inc.

dS Breast 16ch 3.0T

Philips North America Llc

Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Lamine

American Contract Systems, Inc.

Puritan Bennett 980 Series Ventilator, 980X1JADIJJ

Covidien Llc

TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear

GE Healthcare Finland Oy