AVANOS 40-9226Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00350770460383), received between Aug 15, 2023 and Sep 29, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935425 ↗
• MalfunctionJul 27, 2026Leak/Splash; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035045 ↗
• MalfunctionJul 27, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50006166 ↗
• MalfunctionJun 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED VIA FDA MEDWATCH VIA REPORT NUMBER MW5187613 ¿SEVERAL EVENTS OF ENFIT PORT DETACHING FROM TUBE FOR VARIOUS LOTS OF 6FR AND 8FR AVANOS CORFLO FEEDING TUBES. TUBE REPLACEMENTS REQUIRED FOR ALL PATIENTS AFFECTED. PATIENTS REQUIRED TUBE REPLACEMENT UNDER ANESTHESIA COMPLETED IN INTERVENTIONAL RADIOLOGY, ADDITIONAL EXPOSURE TO ANESTHESIA AND RADIATION TO REPLACE DEFECTIVE TUBES. IN ONE EVENT PORT DETACHED AT HOME AND PATIENT REQUIRED ADMISSION FOR CARE AND REPLACEMENT. DEVICE CODE: 2907. PATIENT CODE: 4582. REFERENCE REPORT MW5187614, MW5187615, MW5187616.¿

  Patient problems: Insufficient Information

  MAUDE report 25510337 ↗
• MalfunctionFeb 6, 2026Fracture

  IT WAS REPORTED A NASOJEJUNAL TUBE (NJT) THAT RUPTURED. THE DEVICE WAS INSERTED (B)(6) 2025 VIA RADIOLOGY, PATIENT SELF-REMOVED THE DEVICE ON (B)(6) 2025. THE NJT WAS THEN RE-INSERTED ON THE WARD, (B)(6) 2025, PLACEMENT WAS CONFIRMED BY ABDOMINAL X-RAY. ON (B)(6) 2026 THE DEVICE WAS PLACED AND THE PATIENT WAS PLACED RIGHT SIDE DOWN AND HAD AN ABDOMINAL X-RAY TO CONFIRM POSITION. THE PATIENT WAS PLACED IN A RIGHT LATERAL POSITION. THE TUBE WAS ADVANCED 1-2 CM AT A TIME, WHILE INSTILLING 5 -10 ML OF AIR AND AUSCULTATING THE ABDOMEN UNTIL THE TUBE WAS FURTHER ADVANCED BY 6CM. "THE PATIENT HAD INCREASED MILKY ASPIRATES VIA THEIR NGT, WHEN THE PATIENT WAS FEEDING VIA NJT. GASTRO [TEAM] REVIEWED REGARDING INCREASED GASTRIC OUTPUTS. WAS 50-100MLS LAST 2/7 DAYS, OUTPUTS THEN INCREASED TO 230-280MLS. OUTPUT PREVIOUSLY YELLOW IN COLOUR NOW MILKY OUTPUT." ANTERIOR X-RAY (AXR) PERFORMED (B)(6) 2026 "NJT IN D3-D4 SAME AS AXR (B)(6) 2025. PLAN FROM GASTRO [TEAM] TO FURTHER ADVANCE NJT TO THE CORRECT PLACEMENT. NURSING TEAM ADVANCED 6CM TO 47CM. X-RAY DONE AT 1830 TO CONFIRM PLACEMENT. FRACTURED TIP MISSED ON REVIEW. THE FOLLOWING MORNING ON MEDICAL ROUNDS (B)(6) 2026 NJT FRACTURE NOTED ON X-RAY.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 24284850 ↗
• MalfunctionJan 22, 2026Leak/Splash; Material Puncture/Hole; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00016 FOR THE FIRST REPORT. REFER TO 9611594-2026-00018 FOR THE THIRD REPORT. IT WAS REPORTED, ¿WHAT WE ARE EXPERIENCING IS THE STYLET NOT BE ABLE TO BE REMOVED EASILY KINKING THE NG "[NASOGASTRIC]" TUBE IN THE PATIENTS STOMACH. THERE HAVE BEEN HOLES NOTED NEAR THE END OF TUBE ENFIT SECTION WHERE WE ASPIRATE FLUID TO DO PH FOR PROPER PLACEMENT. UNABLE TO GET ASPIRATE AND THEN NOTED THE TUBE HAD HOLES.¿ PER ADDITIONAL INFORMATION RECEIVED ON 13NOV2025, "NO INJURY OR ADDITIONAL INTERVENTION TOOK PLACE ASIDE FROM TUBE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148760 ↗
• MalfunctionJan 22, 2026Leak/Splash; Material Puncture/Hole; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2026-00016 FOR THE FIRST REPORT, REFER TO 9611594-2026-00017 FOR THE SECOND REPORT. IT WAS REPORTED, ¿WHAT WE ARE EXPERIENCING IS THE STYLET NOT BE ABLE TO BE REMOVED EASILY KINKING THE NG [NASOGASTRIC] TUBE IN THE PATIENTS STOMACH. THERE HAVE BEEN HOLES NOTED NEAR THE END OF TUBE ENFIT SECTION WHERE WE ASPIRATE FLUID TO DO PH FOR PROPER PLACEMENT. UNABLE TO GET ASPIRATE AND THEN NOTED THE TUBE HAD HOLES.¿ PER ADDITIONAL INFORMATION RECEIVED ON 13NOV2025, "NO INJURY OR ADDITIONAL INTERVENTION TOOK PLACE ASIDE FROM TUBE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148686 ↗
• MalfunctionJan 22, 2026Leak/Splash; Material Puncture/Hole; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2026-00017 FOR THE SECOND REPORT; REFER TO 9611594-2026-00018 FOR THE THIRD REPORT. IT WAS REPORTED, ¿WHAT WE ARE EXPERIENCING IS THE STYLET NOT BE ABLE TO BE REMOVED EASILY KINKING THE NG TUBE IN THE PATS STOMACH. THERE HAVE BEEN HOLES NOTED NEAR THE END OF TUBE ENFIT SECTION WHERE WE ASPIRATE FLUID TO DO PH FOR PROPER PLACEMENT. UNABLE TO GET ASPIRATE AND THEN NOTED THE TUBE HAD HOLES." PER ADDITIONAL INFORMATION RECEIVED ON 13NOV2025, "NO INJURY OR ADDITIONAL INTERVENTION TOOK PLACE ASIDE FROM TUBE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148677 ↗
• MalfunctionDec 3, 2025Material Puncture/Hole; Stretched; Material Puncture/Hole; Stretched

  IT WAS REPORTED, ¿PATIENT X-RAY IMPRESSION STATED: "QUESTION FOCAL ANEURYSMAL DILATION/DISRUPTION OF THE FEEDING TUBE WITHIN THE ESOPHAGUS, WITH THE RADIOLUCENT SEGMENT MEASURING 7 MM IN LENGTH. RECOMMEND REMOVING FEEDING TUBE. CALL REPORT MODULE IS INITIATED." TEAM CALLED AND WE REPLACED THE NG TUBE. WHEN REMOVED, FOUND INDEED THERE WAS AN ANEURYSM/POSSIBLE OPENING APPROXIMATELY 6 INCHES ABOVE THE TIP OF THE NG TUBE. TEAM TOOK A PHOTO AND STATED SUSPICION OF A USER FLUSHING TOO HARD TO REMOVE OCCLUSION/SLUGGISHNESS.¿ THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704983 ↗
• MalfunctionMay 16, 2024Break; Break

  IT WAS REPORTED THERE WAS AN INCIDENT OF THE NASOGASTRIC TUBE FRACTURING DURING USE WHILE INSIDE OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED 29-FEB-2024 STATING THE TUBE WAS INDWELLING FOR ONLY 9-DAYS. THE PATIENT HAD A CHEST X-RAY FOR AN UNRELATED ISSUE WHICH SHOWED TIP OF TUBE MISSING. IT WAS NOT NOTICED BY CLINICAL STAFF UNTIL THE NURSE PRACTIONER (NP) REVIEWED X-RAY ON (B)(6) 2024. THE REMAINDER OF TUBE WAS NOT VISIBLE ON X-RAY INDICATING THAT IT MAY HAVE BEEN PASSED BY THE PATIENT. THE TUBE WAS REMOVED AND MEASURED AND CONFIRMED 1CM OF DISTAL END WAS MISSING. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19335176 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THERE WAS AN "NGT (NASOGASTRIC TUBE) BREAK IN AN INFANT. IT WAS FOUND INCIDENTALLY ON X-RAY AND IT WAS POST PYLORIC BUT FORTUNATELY [THE CLINICIANS] WERE ABLE TO REMOVE IT INTACT AT THE BEDSIDE AND SAVED ENDOSCOPIC REMOVAL. THE TUBE BROKE AT THE "9TH CM FROM THE END (IN THE CHILD)." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 01-AUG-2023 STATED THE NGT WAS IN PLACE 22-DAYS PRIOR TO THE REPORTED EVENT. THE TUBE WAS PLACED WITH A STYLET AND WAS FLUSHED WITH 10ML OF WATER THROUGH THE SIDE PORT TO ACTIVATE THE INTERNAL LUBRICANT PRIOR TO STYLET REMOVAL. THE NURSE REPORTED THAT TUBE WAS ¿SLUGGISH¿ THAT MORNING AFTER GIVING MEDS THEREFORE REQUIRED EXTRA FLUSHING. THE DEVICE INITIALLY APPEARED FRACTURED ON X-RAY SO PATIENT WAS MADE NPO (NOTHING BY MOUTH) OVERNIGHT WITH A PLAN TO RETRIEVE THE DEVICE ENDOSCOPICALLY ON (B)(6) 2023 HOWEVER THAT MORNING THE CLINICIANS ATTEMPTED TO PULL IT OUT PRIOR TO PROCEDURE AND THE TUBE CAME OUT IN 1 PIECE (WITH A RIP).

  Patient problems: Foreign Body In Patient

  MAUDE report 17550643 ↗