Menlo Park, CA, United States
Intersect ENT, Inc. recalls
2 recalls recorded since 2018, most recently on 4 January 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 4 January 2023
- Terminated
- 21 August 2024
- Reason
- Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0167-2023
- SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01.
Ongoing Class II Medical devices
- Recall started
- 21 October 2022
- Reason
- Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
- Distribution
- US Nationwide distribution including in the states of NC, IL, KS, OR, WI, TX, FL, MN, WY, UT, NY, CA, NJ, OK, MD, HI, MT, TN, MO, IA, MA, AZ, GA, LA, ID, SC, WA, SD, ND, CO, NV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0458-2023
- Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.