PILLING IPN004227Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04026704417520), received between Jun 14, 2022 and Oct 31, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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.

• MalfunctionOct 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE SPONGES ARE COMING APART FROM THE STRING. THE STRING IS NOT HOLDING THE SPONGES TOGETHER WHEN REMOVING THEM FROM THE PATIENT. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR 3011137372-2023-00237.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041683 ↗
• MalfunctionOct 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE SPONGES ARE COMING APART FROM THE STRING. THE STRING IS NOT HOLDING THE SPONGES TOGETHER WHEN REMOVING THEM FROM THE PATIENT. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR 3011137372-2023-00235.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041419 ↗
• MalfunctionSep 18, 2023Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE DEVICE "HAS BEEN SHEDDING DURING PROCEDURES LEAVING COTTON FIBERS IN THE SURGICAL FIELD. THIS PRODUCT IS USED IN NASAL AND AIRWAY CASES". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17767706 ↗
• MalfunctionJun 14, 2022Unraveled Material; Unraveled Material

  COTTONOIDS FALLING APART IN PATIENT'S NOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685754 ↗