Medical Device Recalls

DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15

DeRoyal Industries Inc

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.

Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI

GE Medical Systems Information Technologies Inc

Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-3

Cook Incorporated

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;

Beaver Visitec International, Inc.

Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software

Alcon Research LLC

Puritan Bennett 980 Series Ventilator, 980U1ENASAA

Covidien Llc

Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiati

Philips North America Llc

REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

Abbott Laboratories

TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.

Howmedica Osteonics Corp.

Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S

Riverpoint Medical, LLC

VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

Ventec Life Systems, Inc.

Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software V

B Braun Medical Inc

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

Smiths Medical ASD Inc.

GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

GE Medical Systems Information Technologies Inc

medex Arterial Kit 1/EA, Product Code REF MX7827

Smiths Medical ASD, Inc.

ASM Replacement Battery, Component Number SUB0000864

ICU Medical Inc

Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyze

Instrumentation Laboratory

Hand Pack, AKHD97C; Medical convenience kit

American Contract Systems, Inc.

Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Produ

Olympus Corporation of the Americas

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RaySta

RAYSEARCH LABORATORIES AB

HIGH V+ Spinal Cement System REF T040321K

TEKNIMED SAS

GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic

GE Healthcare, LLC

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814

BioPro, Inc.

ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)

Synapse PACS - Version 7.2.100

FUJIFILM Healthcare Americas Corporation

Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Sli

Maquet Medical Systems USA

Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

Philips North America Llc

Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

Randox Laboratories Ltd.

EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

Boston Scientific Corporation