Medline CPRM4426Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277700505), received between Oct 20, 2025 and Oct 31, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Decrease in Pressure” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Structural Problem; No Flow; Structural Problem; No Flow

  IT WAS REPORTED THAT THE ISSUE PREVENTS ADEQUATE DELIVERY OF POSITIVE PRESSURE WHEN THE BAG IS NOT HELD PERFECTLY STRAIGHT, AS PRESSURE IS LOST WHEN TORQUE IS APPLIED AT THE JUNCTION TO THE ADAPTER. .THE RESUSCITATION BAG WAS BEING USED TO VENTILATE AND THE PATIENT DESATURATED AND FAILED TO PROGRESS; THE RESUSCITATION BAG WAS REPLACED AND THE PATIENT'S VENTILATION/OXYGEN SATURATION IMPROVED. THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23444226 ↗
• InjuryOct 20, 2025Decrease in Pressure; Decrease in Pressure

  DURING A RESUSCITATION ATTEMPT INVOLVING AN ADULT MALE PATIENT, THE MEDLINE RESUSCITATION BAG REPORTEDLY FAILED TO ADEQUATELY VENTILATE THE PATIENT. THE PATIENT EXPERIENCED DESATURATION AND DID NOT IMPROVE WHILE THE MEDLINE DEVICE WAS IN USE. UPON SWITCHING TO A PREVIOUSLY STOCKED RESUSCITATION BAG FROM ANOTHER BRAND, VENTILATION IMPROVED AND THE PATIENT'S OXYGEN SATURATION INCREASED. THE FACILITY REPORTED PROBLEMS WITH ADEQUATE DELIVERY OF POSITIVE PRESSURE WHEN THE BAG IS NOT HELD PERFECTLY STRAIGHT, AS PRESSURE IS LOST WHEN TORQUE IS APPLIED AT THE JUNCTION TO THE ADAPTER.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23336402 ↗