The FDA has posted 5 enforcement recalls of emergency response safety kit devices since 2025, including 5 Class I (most serious) recalls. Most recent report: Feb 4, 2026.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Emergency Response Safety Kit”). Informational only — verify against the FDA before acting.