Eagan, MN, United States
Summit Medical, LLC recalls
1 recall recorded since 2018, most recently on 13 January 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 13 January 2023
- Terminated
- 14 August 2026
- Reason
- Sterile product pouches were not sealed.
- 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
- Voluntary: Firm initiated
- Recall number
- Z-1171-2023
- Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.