Brand
Acclarent, Inc. Recalls
9 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Acclarent, Inc..
9Total Recalls
0Critical
10,916Units Affected
Sep 21, 2023Most Recent
All Recalls
Every Acclarent, Inc. Recall
Sorted by most recent. Click any recall for full details.
9 recalls
High RiskFDA
Acclarent, Inc.
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Medical Devices141 affectedSep 21, 2023
High RiskFDA
Acclarent, Inc.
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Medical Devices0 affectedMar 6, 2019
High RiskFDA
Acclarent, Inc.
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
Medical Devices0 affectedMar 6, 2019
RecallFDA
Acclarent, Inc.
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to acces...
Surgical Devices986 affectedApr 28, 2015
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Medical Devices1,920 affectedJan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices2,703 affectedJan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices625 affectedJan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices1,217 affectedJan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices3,324 affectedJan 11, 2013