FDA Device recall Z-0458-2023
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
- FDA Device
- Class II
- ongoing
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044 by Intersect Ent, citing sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0458-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-21 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Intersect Ent |
| Distribution | US |
Product
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Reason
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Identifiers
| code_info | REF: 60044, UDI-DI: M927600440, Lot: 22041901 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0458-2023%22
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