AVANOS 40-8226Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770460352), received between Dec 13, 2022 and Jun 18, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

• MalfunctionJun 18, 2026Complete Blockage

  IT WAS REPORTED THAT A NASOGASTRIC TUBE COULDN'T BE FLUSHED AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552591 ↗
• MalfunctionOct 4, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED, WHEN CHECKING FOR GASTRIC CONTENTS THE NASOGASTRIC TUBE (NGT) WAS ONLY PULLING OUT AIR, UPON CLOSER INSPECTION, THE BEDSIDE NURSE NOTED PUNCTURE MARKS ON THE NGT. WHEN THE NGT WAS COMPLETELY REMOVED FROM THE PATIENT ¿LITTLE TINY YELLOW HAIRS¿ WERE SEEN, THEY APPEARED TO BE SHREDS OF THE NGT STUCK ON THE GUIDEWIRE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369560 ↗
• MalfunctionOct 3, 2024Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2024-00209 FOR THE SECOND EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362419 ↗
• InjuryDec 13, 2022Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH/FDA USER FACILITY REPORT # MW (B)(4) THE FOLLOWING INFORMATION: NASOJEJUNAL (NJ) TUBE CLOGGED AND WAS FLUSHED WITH VIOKACE TO HELP RESOLVE. LATER THAT EVENING PATIENT NOTED TO HAVE ABDOMINAL DISTENTION. X-RAY REVEALED FRACTURED TUBE AND PNEUMOPERITONEUM. PATIENT WENT TO OR FOR REPAIR OF THE BOWEL AND REMOVAL [OF] THE NJ TUBE." ADDITIONAL INFORMATION RECEIVED 22-NOV-2022 STATED THE DEVICE WAS IN PLACE ON DAY-1. UNFORTUNATELY, THE PATIENT REQUIRED SURGICAL INTERVENTION."

  Patient problems: Abdominal Distention; Pneumothorax

  MAUDE report 15974345 ↗