FDA Device recall Z-1171-2023
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile
- FDA Device
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile by Summit Medical, citing sterile product pouches were not sealed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1171-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-01-13 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Summit Medical |
| Distribution | CO, FL, GA, LA, MA, ME |
Product
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Reason
Sterile product pouches were not sealed.
Identifiers
| code_info | Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1171-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.