Official recall record

Adult Manual Resuscitator

Health Canada — Medical Devices · 2025-05-16 · CanadaType I

Issuing authority: Health Canada — Medical Devices
Published: 2025-05-16
Country of alert: Canada
Alert level: Type I
Alert type: recall

What the authority reported

Medline was informed by its contract manufacturer that the Adult Manual Resuscitator with mask, bag reservoir, and filter, CPRM1116F, was misassembled. Instead of the filter pre-attached at the exhalation port, it was connected to the patient port where the mask attaches. If the filter is incorrectly attached and not noticed before patient use, there could be a potential delay in patient resuscitation, which may result in life-threatening consequences, including hypoxia, hypercapnia, organ failure or death. Recall Start Date: May 9, 2025

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: Health Canada — Medical Devices · Canada · all filters

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