Class II — Summit Medical, LLC
| Recalling firm | Summit Medical, LLC |
|---|---|
| Registered facility | SUMMIT MEDICAL LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Sterile product pouches were not sealed. |
| Product | Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. |
| Quantity | 30 devices |
| Distribution | US Distribution was made to CO, FL, GA, LA, MA, and ME. There was no government/military distribution. OUS Foreign distribution was made to Canada. |
| Initiated | 2023-01-13 |
| Classified | 2023-02-24 |
| Terminated | 2026-08-14 |
| Recall number | Z-1171-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Summit Medical, LLC (Z-1171-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91527/
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