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Medline Industries, Inc. CPRM1116FRecalls & reported problems

Medline Industries, Inc. · RESUSCITATOR,MAN.ADLT,BAG,FILTER · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. May 1, 2025Class IOpen, Classified

    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.

    Z-1814-2025 · Root cause: Process control · Recall details · FDA record ↗

Other Ventilator, emergency, manual (resuscitator) devices

All Ventilator, emergency, manual (resuscitator) devices →

Sources and updates

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