Acclarent recalls

Acclarent has 13 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 1 Nov 2023. 2 are still ongoing.

Total recalls13since 2013

Last 12 months0reported

Class I00% of total

Ongoing2latest 1 Nov 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 12 92%Class III 1 8%

Why acclarent is recalled

Product types

Heart & Vascular Devices862%
Other Medical Devices538%

By year

202318%
202118%
2020323%
201518%
2013754%

Ongoing acclarent recalls

2 active

Reported	Class	Recall	Company	Reason	Where
1 Nov 2023Device	CLASS II	TruDi Navigation System recalled by Acclarent	Acclarent	Packaging Defects	30 states
29 Dec 2021Device	CLASS II	TruDi NAV Suction Instruments: 0-Degree recalled by Acclarent	Acclarent	Lead & Heavy Metals	39 states

All acclarent recalls, newest first

13 total

Reported	Class	Recall	Company	Reason	Where
1 Nov 2023Device	CLASS II	TruDi Navigation System recalled by Acclarent	Acclarent	Packaging Defects	30 states
29 Dec 2021Device	CLASS II	TruDi NAV Suction Instruments: 0-Degree recalled by Acclarent	Acclarent	Lead & Heavy Metals	39 states
29 Jan 2020Device	CLASS II	TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle recalled by Acclarent	Acclarent	Other	6 states
29 Jan 2020Device	CLASS II	TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle recalled by Acclarent	Acclarent	Other	6 states
29 Jan 2020Device	CLASS II	TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle recalled by Acclarent	Acclarent	Other	6 states
17 Jun 2015Device	CLASS III	Relieva Flex Sinus Guide Catheter F recalled by Acclarent	Acclarent	Other	TX
7 Aug 2013Device	CLASS II	Inspira AIR Balloon Dilation system recalled by Acclarent	Acclarent	Other	Nationwide
7 Aug 2013Device	CLASS II	Inspira AIR Balloon Dilation system recalled by Acclarent	Acclarent	Other	Nationwide
7 Aug 2013Device	CLASS II	Inspira AIR Balloon Dilation system recalled by Acclarent	Acclarent	Other	Nationwide
7 Aug 2013Device	CLASS II	Inspira AIR Balloon Dilation system recalled by Acclarent	Acclarent	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.