AVANOS 44124Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770441245), received between Jun 18, 2025 and Aug 21, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 31, 2024Open, Classified

   The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

   Z-2422-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Inadequacy of Device Shape and/or Size; Unintended Movement; Inadequacy of Device Shape and/or Size; Unintended Movement

  IT WAS REPORTED THE PATIENT BELIEVES TUBE SIZE IS TOO SMALL. THE PATIENT WAS UNABLE TO GET A GAUZE BETWEEN THE ABDOMEN AND THE TUBE AND THERE WAS BLEEDING. THE PATIENT PLANS TO SEE PHYSICIAN FOR SIZING. ADDITIONAL INFORMATION RECEIVED (B)(6) 2025 STATING THE PATIENT WAS "TREATED FOR INFECTION WITH ABOUT 20-DAYS OF ORAL ANTIBIOTICS FOR A RESPIRATORY INFECTION SUSPECTED TO BE CAUSED FROM ASPIRATING DURING THAT PROCEDURE PLUS THE GJ [GASTROJEJUNAL] STOMA SITE [WHICH] LOOKED INFECTED TOO AFTER ITS PLACEMENT LIKELY DUE TO ITS IMPROPER SIZE. IT HAS CONTINUED TO BLEED INTERMITTENTLY AND HAS GRANULATION TISSUE THAT IS INFLAMED BUT DOESN'T LOOK INFECTED ANYMORE." THE PATIENT WAS SCHEDULED FOR A (B)(6) 2025 DEVICE REPLACEMENT RELATED TO SIZING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22868860 ↗
• InjuryJun 18, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED, PATIENT PHONE CALL REPORTS THERE IS NOT ADEQUATE SPACE BETWEEN THE HEAD OF THE MIC-KEY GASTROJEJUNAL (GJ) AND HER ABDOMEN. REPORTS THIS HAS CAUSED REDNESS AND IRRITATION TO HER SKIN. PATIENT USUALLY USES A MIC GJ FEEDING TUBE. STOMA SITE HAS BEEN ESTABLISHED SINCE (B)(6) 2024. ON (B)(6) 2025 HAD PLACEMENT PROCEDURE FOR MIC-KEY GJ AND DEVELOPED FEVER AFTER THE PROCEDURE. CURRENTLY FOLLOWING GUIDANCE OF PRIMARY CARE PHYSICIAN TO START BACTRIM. LAB WORK PENDING.

  Patient problems: Fever; Skin Inflammation/ Irritation

  MAUDE report 22285440 ↗