# FDA recall Z-0458-2023

> **Intersect ENT, Inc.** · Class II · device recall initiated 2022-10-21.

## Product

Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

## Reason for recall

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.

## Key facts

- **Recall number:** Z-0458-2023
- **Recalling firm:** Intersect ENT, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-21
- **Report date:** 2022-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Menlo Park, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2023

## Citation

> AI Analytics. FDA recall Z-0458-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0458-2023. Source: US FDA. Licensed CC0.

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