Medical Device Recalls

medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

Smiths Medical ASD, Inc.

Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DR

Medline Industries, LP

regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

ROi CPS LLC

Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE

MEDLINE INDUSTRIES, LP - Northfield

Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3

Getinge Usa Sales Inc

stay-safe /Safe Lock Catheter Ext. 12 in

Fresenius Medical Care Holdings, Inc.

Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous

Biomet, Inc.

GS DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GS DENTURE CLEAN OVRNT TAB 40CT, SKU 906023

Family Dollar Stores, Llc.

Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcar

EMPATICA SRL

Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated

Steris Corporation

Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23

LimFlow, Inc.

Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; radiation monitoring d

Landauer

REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 m

Becton Dickinson Infusion Therapy Systems, Inc.

Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BA

American Contract Systems Inc.

BD Pyxis MedBank System - Product Label/labeling pending

CareFusion 303, Inc.

STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612

Diagnostica Stago, Inc.

Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description

Sonesta Medical AB

Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monit

Edwards Lifesciences, LLC

Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 206

GE Healthcare

ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Fed

Neuralynx Inc

OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incis

LUMENIS, LTD.

Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

XTANT Medical Holdings, Inc

Halyard, Eye Bag Pack. Kit Code: UIEB48-01.

AVID Medical, Inc.

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044

Covidien, LP

DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

Delta Med SpA

bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

B-K Medical A/S

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

Zimmer, Inc.

IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyze

Siemens Healthcare Diagnostics, Inc.

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382025

TELEFLEX LLC

Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797

Volcano Corp