Medline ReNewal N2FOURPORTRRecalls & reported problems
Medline Industries, Inc. · MANIFOLD, FOUR PORT, NEP2, REPROCESSED · Class 2
All models of Medline ReNewal (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888277188648), received between May 31, 2026 and Sep 25, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (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
- Communication or Transmission Problem1
- Data Problem1
- Failure to Read Input Signal1
- No Device Output1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901743 ↗MalfunctionSep 24, 2026Failure to Read Input Signal; Data Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890045 ↗MalfunctionMay 31, 2026No Device Output
IT WAS REPORTED THAT, MANIFOLDS THAT ARE NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344070 ↗
Other TRAP, STERILE SPECIMEN devices
- MEDLINE DYND44110Medline Industries, Inc. · TRAP, STERILE SPECIMEN8 reports
- MEDLINE DYND44108Medline Industries, Inc. · TRAP, STERILE SPECIMEN2 reports
- N/a 5400-800-000Stryker Corporation · TRAP, STERILE SPECIMEN1 report
- Medline DYND44140Medline Industries, Inc. · TRAP, STERILE SPECIMEN1 report
- Medline DYND44180Medline Industries, Inc. · TRAP, STERILE SPECIMEN1 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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