CLASS II ONGOING Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
Propel Mini Mometasone Furoate Sinus Implant recalled by Intersect ENT
Intersect ENT is recalling Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, distributed nationwide in the US. The recall was initiated on 21 Oct 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0458-2023
- FDA event ID
- 91063
- Recalling firm
- Intersect ENT, Menlo Park, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Oct 2022
- FDA classified
- 8 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 21 Oct 2022 | Recall initiated by company | |
| 8 Dec 2022 | Classified by FDA | +48 days |
| 14 Dec 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIowaIdahoIllinoisKansasLouisianaMassachusettsMarylandMinnesotaMissouriMontanaNorth CarolinaNorth DakotaNew JerseyNevada
Questions about this recall
Why was it recalled?
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Which lots are affected?
REF: 60044, UDI-DI: M927600440, Lot: 22041901
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Intersect ENT
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Sinuva (mometasone furoate) sinus implant, 1350 mcg, 1 implant recalledSinuva | Intersect ENT | Potency & Assay | Nationwide |
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