Recall database

Ventilator, Emergency, Manual (Resuscitator) recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–3 of 3 recalls

Class IOngoingZ-2357-2026

Datex-Ohmeda Inc recalls Giraffe Stand-alone Infant Resuscitation System

Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in…

Datex-Ohmeda IncWIJun 24, 2026

Class IOngoingZ-2181-2025

Ambu Inc. recalls Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator

Potential for the manometer port being blocked rendering the manometer non-functional.

Ambu Inc.MDAug 20, 2025

Class IOngoingZ-1814-2025

SunMed Holdings, LLC recalls Adult Manual Resuscitator with Medium Adult Mask

Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port).…

SunMed Holdings, LLCMIJun 11, 2025