Medical Device Recalls

Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administrati

B. Braun Medical, Inc.

Smart Toe II Intramedullary Arthrodesis Implant

Stryker GmbH

Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Steri

Jiangsu Shenli Medical Production Co., Ltd.

ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump

ICU Medical, Inc.

Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Ari

Securitas Healthcare LLC

Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:

Orthofix U.S. LLC

ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators

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

Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Ster

Jiangsu Shenli Medical Production Co., Ltd.

Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syri

Jiangsu Shenli Medical Production Co., Ltd.

DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.

Aesculap Inc

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm

Mozarc Medical US LLC

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

MEDLINE INDUSTRIES, LP - Northfield

PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103

Heartware, Inc.

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137

Beckman Coulter, Inc.

Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain

The Metrix Company

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma ou

ConvaTec, Inc

Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801

C.R. Bard Inc

cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190

Roche Molecular Systems, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter

Boston Scientific Corporation

Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magneti

ENDOMAGNETICS LTD

Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectr

Philips North America Llc

Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY

MEDLINE INDUSTRIES, LP - Northfield

JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240

Boston Scientific Corporation

ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product N

Ethicon Endo-Surgery Inc

Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product

Angiodynamics, Inc.

Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS20

CPM Medical Consultants, LLC.

VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051

Biomerieux Inc

ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators

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

SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 1801

Alcon Research, LLC

HENRY SCHEIN, Labiaplasty PackItem No.570-3118,

Stradis Medical, LLC dba Stradis Healthcare