FDA Device Intelligence
HomeDevice types › OKI

Emergency Response Safety Kit

FDA product code OKI · Class 2 · General, Plastic Surgery

107
Registered devices
28
Adverse events
5
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-12-15SunMed Holdings, LLCProduct contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
2025-12-15SunMed Holdings, LLCProduct contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
2025-12-15SunMed Holdings, LLCProduct contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
2025-12-15SunMed Holdings, LLCProduct contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
2025-05-15SunMed Holdings, LLCThe impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the i

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 docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.