AVANOS 44627Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770446271), received between Jun 20, 2022 and May 13, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

14 other recalls cover devices cleared under the same FDA submission (K924065); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3006646024-2026-00031 FOR THE FIRST REPORT. REFER TO 3006646024-2026-00032 FOR THE SECOND REPORT. IT WAS REPORTED THAT A PATIENT WITH OESOPHAGEAL APLASIA UNDERWENT AN OESOPHAGECTOMY. POST-OPERATIVE OESOPHAGEAL STRICTURE REQUIRING THREE SESSIONS OF OESOPHAGEAL DILATION UP TO 18 MM. IT WAS NOT POSSIBLE TO REMOVE THE FEEDING TUBE COLLAR ENDOSCOPICALLY. THE FEEDING TUBE COLLAR WAS LEFT INTRAGASTRIC TO PASS NATURALLY. AN OPERATION TOOK PLACE ON (B)(6) 2026. THE PATIENT IS FINE NOW.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 25161707 ↗
• InjuryMay 13, 2026Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2026-00031 FOR THE FIRST REPORT. REFER TO 3006646024-2026-00032 FOR THE SECOND REPORT. IT WAS REPORTED THAT A GASTROSTOMY TUBE REMOVED ON (B)(6) 2026. IT WAS NOT POSSIBLE TO PASS THE UPPER OESOPHAGEAL SPHINCTER ENDOSCOPICALLY. THE TUBE COLLAR WAS LEFT IN THE STOMACH TO PASS NATURALLY. SUBSEQUENTLY, AN OBSTRUCTION OCCURRED. THE PATIENT UNDERWENT AN OPERATION ON (B)(6) 2026. THE PATIENT IS FINE NOW.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 25161701 ↗
• InjuryJun 20, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED 'THE FLANGE THAT HOLDS THE TUBE IS SO FLEXIBLE THAT THE TUBE COMES OUT OF THE STOMACH.' THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 24-MAY-2022 STATED 'THE PATIENT'S CONDITION IS DEGRADED. PASSAGE OF NUTRITION OUTSIDE THE STOMACH, WALL ABSCESS. SURGICAL INTERVENTION TO DRAIN THE ABSCESS.'

  Patient problems: Abscess

  MAUDE report 14750572 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924065. One submission often covers many models, so check the product and lot details in each record.

• Z-2348-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
• Z-2342-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
• Z-2345-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
• Z-2350-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
• Z-2341-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit
• Z-2344-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
• Z-2352-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
• Z-2343-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
• Z-2351-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
• Z-2347-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Comp
• Z-2346-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
• Z-2349-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
• Z-0566-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
• Z-0565-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL