FDA Device Recalls

Class ITerminated

ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-40/I20-40, BEA22-120/I16-40, BEA22-100/I16-40, BEA22-80/I16-40, BEA22-60/I16-40, BEA22-40/I16-40, BEA22-120/I13-40, BEA22-100/I13-40, BEA22-80/I13-40, BEA22-60/I13-40, BEA22-40/I13-40, BEA22-110/I20-30, BEA22-90/I20-30, BEA22-70/I20-30, BEA22-50/I20-30, BEA22-110/I16-30, BEA22-90/I16-30, BEA22-70/I16-30, BEA22-50/I16-30, BEA22-100/I20-55, BEA22-80/I20-55, BEA22-100/I16-55, BEA22-80/I16-55, BEA25-120/I20-40, BEA25-100/I20-40, BEA25-80/I20-40, BEA25-60/I20-40, BEA25-40/I20-40, BEA25-120/I16-40, BEA25-100/I16-40, BEA25-80/I16-40, BEA25-60/I16-40, BEA25-40/I16-40, BEA25-120/I13-40, BEA25-100/I13-40, BEA25-80/I13-40, BEA25-60/I13-40, BEA25-40/I13-40, BEA25-110/I20-30, BEA25-90/I20-30, BEA25-70/I20-30, BEA25-50/I20-30, BEA25-110/I16-30, BEA25-90/I16-30, BEA25-70/I16-30, BEA25-50/I16-30, BEA25-100/I20-55, BEA25-80/I20-55, BEA25-100/I16-55, BEA25-80/I16-55, BEA28-120/I20-40, BEA28-100/I20-40, BEA28-80/I20-40, BEA28-60/I20-40, BEA28-40/I20-40, BEA28-120/I16-40, BEA28-100/I16-40, BEA28-80/I16-40, BEA28-60/I16-40, BEA28-40/I16-40, BEA28-120/I13-40, BEA28-100/I13-40, BEA28-80/I13-40, BEA28-60/I13-40, BEA28-40/I13-40, BEA28-110/I20-30, BEA28-90/I20-30, BEA28-70/I20-30, BEA28-50/I20-30, BEA28-110/I16-30, BEA28-90/I16-30, BEA28-70/I16-30, BEA28-50/I16-30, BEA28-100/I20-55, BEA28-80/I20-55, BEA28-100/I16-55, BEA28-80/I16-55

Endologix

Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.

July 31, 2018 · DeviceView details →

CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.

ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.

CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.

OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.

DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

The Tri-Flo Subglottic Suction System

AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.