Medline Industries, Inc. CPRM1126FPRecalls & reported problems
Medline Industries, Inc. · RESUSCITATOR,MAN.ADLT,TUBE,FILTER,PEEP · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196521142), received between Feb 18, 2025 and Feb 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Improper Flow or Infusion1
- Infusion or Flow Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2025Infusion or Flow Problem; Infusion or Flow Problem
BVM OR OXYGEN FLOW MALFUNCTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21404979 ↗MalfunctionFeb 18, 2025Improper Flow or Infusion; Improper Flow or Infusion
BVM OR OXYGEN FLOW MALFUNCTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21401627 ↗
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- Ventlab AF2142MC-3Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
- Ventlab AF1140MB-PVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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