JACKSON REES 3771Y-WSNRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00612649188683), received between Sep 5, 2025 and Sep 5, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Restricted Flow rate” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Restricted Flow rate; Restricted Flow rate

  A BREATHING CIRCUIT (JACKSON-REES) WAS REPORTED TO EXHIBIT INCREASED RESISTANCE DURING CLINICAL USE. THE HEALTHCARE PROFESSIONAL NOTED THE BAG WAS NOT DEFLATING PROPERLY AND UPON INSPECTION, OBSERVED THAT THE TRIANGULAR OPENINGS ON THE APL (ADJUSTABLE PRESSURE-LIMITING) VALVE SEEMED TO BE PARTIALLY OCCLUDED, LIMITING AIRFLOW AND CAUSING INCREASED RESISTANCE. NO PATIENT INJURY OCCURRED. THE REPORT INDICATED THAT THIS CONDITION COULD LEAD TO ELEVATED PRESSURES THAT COULD POTENTIALLY RESULT IN LUNG DAMAGE IF NOT DETECTED TIMELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22985603 ↗