Medical Device Recalls

Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical

Agfa Healthcare NV

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C

Medtronic Neuromodulation

8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

Intuitive Surgical, Inc.

Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000

Landauer

MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)

Medtronic MiniMed, Inc.

Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, p

SURGIFY MEDICAL OY

Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B

MEDLINE INDUSTRIES, LP - Northfield

Blood Pump Rotor, Model Number: F40015481 Rev A

Fresenius Medical Care Holdings, Inc.

VITEK 2 Systems and VITEK 2 with MYLA.

bioMerieux, Inc.

Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int

Beckman Coulter, Inc.

Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.

Fisher Diagnostics

Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS9

MEDLINE INDUSTRIES, LP - Northfield

Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use

Erbe USA Inc

Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGR

Medline Industries, LP

DeRoyal SHOULDER PACK, REF 89-9449.13

DeRoyal Industries Inc

HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002

Access Vascular, Inc

GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"

GE Healthcare, LLC

Brilliance iCT; Product Code (REF): 728306;

Philips North America Llc

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product

Olympus Corporation of the Americas

Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Ve

Integra LifeSciences Corp.

ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3)

GE Medical Systems, LLC

LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

LINK BIO CORP

BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machi

Maquet Medical Systems USA

Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ90

MEDLINE INDUSTRIES, LP - Northfield

REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile

Orthofix Srl

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Zimmer, Inc.

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Moni

Edan Diagnostics

smiths medical Medfusion Model 3500 Syringe pump

Smiths Medical ASD Inc.

Coryell Memorial Hosp Total, Joint Pack - Surgical Kit

Stradis Medical, LLC dba Stradis Healthcare