SUMMIT MEDICAL SP-78105Recalls & reported problems
Summit Medical, Inc. · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K982667); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jan 13, 2023Class IITerminated
Sterile product pouches were not sealed.
Z-1171-2023 · Root cause: Process control · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K982667. One submission often covers many models, so check the product and lot details in each record.
- Z-0347-2011 · Mar 15, 2010 · TerminatedSP78100, SP78105 Nasal Products, Catalog Number SP-78100, Nasal Septal Button Standard (3cm), Rx Only, Sterilized by Ethylene Oxide, Micromedics Inc., St Paul, MN 55121-1385. Nasa
Other Button, Nasal Septal devices
- InHealth Technologies; Blom-Singer SP 2113Freudenberg Medical, LLC · Button, Nasal Septal1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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