Home › Summit Medical, Inc. › SUMMIT MEDICAL
SUMMIT MEDICAL
Summit Medical, Inc. · Model LS7012 · UDI-DI 00385640052016
BYY
Prescription
10
510(k) clearances
216
Adverse events (2 deaths)
6
Recalls
170
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-15 | DeRoyal Industries Inc | The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay i |
| 2008-04-21 | Mentor Texas, Inc | During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices. |
| 2003-11-07 | Vital Concepts, Inc. | The probe may separate from the cannula. |
| 2003-11-07 | Vital Concepts, Inc. | The probe may separate from the cannula. |
| 2003-11-07 | Vital Concepts, Inc. | The probe may separate from the cannula. |
| 2003-11-07 | Vital Concepts, Inc. | The probe may separate from the cannula. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.