SunMed Holdings, LLC recalls Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F

Recall date

May 1, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1814-2025

FDA classification

Class I

Brand / firm

SunMed Holdings, LLC

Sold / distributed

US Nationwide distribution via Medline.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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