The FDA has posted 6 enforcement recalls from SunMed Holdings, LLC since 2025, including 6 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.…
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port).…
Firm name as filed with the FDA: “SunMed Holdings, LLC”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.