FDA Device Recalls

Class IITerminated

INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta

Maquet Cardiovascular, LLC

Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm

April 29, 2022 · DeviceView details →

Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521

Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C

#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

Alcon Clareon IOL with AutonoMe Delivery System

KWIK-STIK" plus: Clostridium perfringens

Arrow Three-Lumen CVC

Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700

Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

FIRMap" Catheter, 60mm Basket

In-Line ventilator adaptor

TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

In-Line ventilator adaptor

SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

Colonovideoscope Model CF-H180AL