Summit Medical Nasal Septal Button — Class II medical device recall Z-1171-2023
Terminated recall by Summit Medical, LLC, reported 2023-03-08, distributed in CO, FL, GA, LA, MA, ME. Sterile product pouches were not sealed.
| Recall number | Z-1171-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Summit Medical, LLC, Eagan, MN, United States |
| Recall initiated | 2023-01-13 |
| Classified | 2023-02-24 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2026-08-14 |
| Distributed | CO, FL, GA, LA, MA, ME |
| Countries outside the US | CA |
| Quantity | 30 devices |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00385640065214 |
| Lot numbers | 219349 |
| Model numbers | P-78105 |
| Expiration dates | 2027-11-01 |
Product
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Reason for recall
Sterile product pouches were not sealed.
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-1171-2023. 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.