Nomoline 9921Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843997014328), received between Sep 10, 2021 and Sep 4, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Readings” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THAT THE DEVICE PROVIDES INTERMITTENT READINGS. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974425 ↗
• MalfunctionSep 10, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE MODULE READS WAY TOO LOW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455417 ↗
• MalfunctionSep 10, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE MODULE READS WAY TOO LOW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455396 ↗
• MalfunctionSep 10, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE MODULE READS WAY TOO LOW. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455353 ↗