Medical Device Recalls

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.

Microbiologics Inc

medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

Smiths Medical ASD, Inc.

SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use on

Med Michigan Holding Llc

IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration

IVOCLAR VIVADENT AG

190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Fresenius Medical Care Holdings, Inc.

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS98

MEDLINE INDUSTRIES, LP - Northfield

Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B

MEDLINE INDUSTRIES, LP - Northfield

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2

Vyaire Medical

Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed

Baxter Healthcare Corporation

Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La

B Braun Medical Inc

Allergy test Small

GET TESTED INTERNATIONAL AB

Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

Philips North America

GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"

GE Healthcare, LLC

Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

Siemens Healthcare Diagnostics, Inc.

NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08

Fresenius Medical Care Renal Therapies Group, LLC

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETA

MEDLINE INDUSTRIES, LP - Northfield

Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-R

Baxter Healthcare Corporation

Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/C

Medline Industries, LP

Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version:

Alcon Research LLC

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Ansell Healthcare Products LLC

VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrate

Merge Healthcare, Inc.

ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,

Implant Direct Sybron Manufacturing LLC

Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small O

GE Medical Systems, LLC

Intera 1.5T Achieva IT Nova Product Number: 781175

Philips North America

SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Mod

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

Beckman Coulter, Inc.

Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number

MEDLINE INDUSTRIES, LP - Northfield

Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

Oxoid Limited

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 6032001010

Zimmer Surgical Inc

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Mallinckrodt Pharmaceuticals Ireland Ltd