Medical Devices Recalls

Intera 1.0T Omni/Stellar, Model Number: 781102;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.

AVID Medical, Inc.

Enterprise 1.5T, Model Number: 781145;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric s…

Richard Wolf GmbH

Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLi…

Vyaire Medical

Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction…

Abbott Molecular, Inc.

Intera 1.5T Omni/Stellar, Model Number: 781104;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Intera 0.5T Standard, Model Number: 781101;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayT…

Klinika Mdical Gmb

Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm …

Meddev Corp

Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.

Baxter Healthcare Corporation

Intera 3.0T Quasar Dual, Model Number: 781150;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Intera 1.5T Power/Pulsar, Model Number: 781105;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.

Medical Depot Inc.

Intera 1.5T R11, Model Number: 781170;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Ped…

Philips North America Llc

CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PU…

Smiths Medical ASD, Inc.

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

Philips Medical Systems Nederland B.V.

Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

Remote Diagnostic Technologies Ltd.

Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation insti…

WANDERCRAFT SAS

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21…

Smiths Medical ASD, Inc.

GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other intervent…

Galt Medical Corporation

CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.

Integra LifeSciences Corp. (NeuroSciences)

CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-…

Smiths Medical ASD, Inc.

B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introd…

Galt Medical Corporation

CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CAD…

Smiths Medical ASD, Inc.

INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.

Integra LifeSciences Corp. (NeuroSciences)

Artix MT Thrombectomy Device, REF: 32-102

Inari Medical - Oak Canyon

Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830

MEDLINE INDUSTRIES, LP - Northfield

CADD Solis HSPCA Pump

Smiths Medical ASD, Inc.

Washer Disinfector Aquadis 56; Model Number: 56M

Getinge Disinfection Ab

B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indica…

Galt Medical Corporation

Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

SCIENCE & BIO MATERIALS

Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

Tornier S.A.S.

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

Bausch & Lomb Surgical, Inc.

Washer Disinfector Aquadis 56; Model Number: 56A

Getinge Disinfection Ab

DEMDACO Recalls Maril Brand Scented Candles Due to Laceration and Fire Hazards

DEMDACO, of Leawood, Kansas

Legend Brands Recalls Bliss Hair Dryers Due to Risk of Serious Injury or Death from Electrocution and Shock Hazards; Sold Exclusively at Burlington S…

GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002

GE Medical Systems China Co., Ltd.

GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000

GE Medical Systems China Co., Ltd.

3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 …

Belmont Instrument LLC

myQA iON; Article Number: MQ10-000;

IBA Dosimetry GmbH

Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cement…

Waldemar Link GmbH & Co. KG (Mfg Site)

Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md…

Waldemar Link GmbH & Co. KG (Mfg Site)

Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French langua…

Defibtech, LLC

GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002

GE Medical Systems China Co., Ltd.

IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Fr…

Boston Scientific Corporation

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4…

Beckman Coulter Inc.

Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792

MEDLINE INDUSTRIES, LP - Northfield

Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF D…

MEDLINE INDUSTRIES, LP - Northfield