Class I

Medical Device Recall: Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

SunMed Holdings, LLC · May 1, 2025

Reason for Recall

Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.

Distribution

US Nationwide distribution via Medline.

States Affected

NATIONWIDE

Quantity Affected

11,358

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1814-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.