Medical Device Recalls

Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-

Penner Patient Care, Inc.

BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEM

BioPro, Inc.

Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F

Edwards Lifesciences, LLC

NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Howmedica Osteonics Corp.

Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekt

Elekta, Inc.

MiniMed 740G Insulin Pump (O.U.S. Version)

Medtronic MiniMed

SM_40HF_BDC3, Mobile X-ray system

SEDECAL SA

DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06

DeRoyal Industries Inc

Puritan Bennett 980 Series Ventilator, 980X3ENDIUU

Covidien Llc

vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a pe

Boston Scientific Corporation

MAMMOMAT Inspiration;

Siemens Medical Solutions USA, Inc

ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar

B Braun Medical Inc

DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apher

Angiodynamics, Inc.

Impella CP Smart Assist Set APAC; Product Code: 0048-0047;

Abiomed, Inc.

Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version

Medimaps Group

Optima XR200amx, Mobile Digital-Ready Radiographic System

GE Medical Systems, LLC

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A

Edwards Lifesciences, LLC

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

Covidien, LP

GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system

GE Medical Systems Information Technologies Inc

Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615

Corin Ltd

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100

Baxter Healthcare Corporation

Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interv

Olympus Corporation of the Americas

X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.

XTANT Medical

Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy fr

Boston Scientific Corporation

Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

Biomet, Inc.

MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)

Medtronic MiniMed, Inc.

Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the p

ICU Medical Inc.

Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

Creganna Medical Devices

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab

Baxter Healthcare Corporation

ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators

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