Propel Mini Mometasone Furoate Sinus Implant — Class II medical device recall Z-0458-2023
Ongoing recall by Intersect ENT, Inc., reported 2022-12-14, distributed nationwide. Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with
| Recall number | Z-0458-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intersect ENT, Inc., Menlo Park, CA, United States |
| Recall initiated | 2022-10-21 |
| Classified | 2022-12-08 |
| Reported by FDA | 2022-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 611 units |
| Reason classes | labeling |
| Lot numbers | 22041901 |
| Model numbers | 60044 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0458-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.