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FDAMay 1, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

sunmed

UPCs

1088438916482240884389164823

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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