AVANOS 40-9366Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00350770460420), received between Jul 28, 2021 and Aug 19, 2026 — classified as 3 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Stretched

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324823 ↗
• MalfunctionAug 6, 2026Break; Complete Blockage

  Patient problems: Foreign Body In Patient

  MAUDE report 50158925 ↗
• MalfunctionJul 27, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024478 ↗
• MalfunctionJul 14, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812191 ↗
• MalfunctionJul 14, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812184 ↗
• MalfunctionJul 6, 2026Leak/Splash

  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 9611594-2026-00529 FOR THE FIRST REPORT. REFER TO 9611594-2026-00530 FOR THE SECOND REPORT. IT WAS REPORTED THAT A NASOGASTRIC TUBE LEAKED ABOVE THE Y-PORT. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25718508 ↗
• MalfunctionJul 6, 2026Leak/Splash

  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 9611594-2026-00530 FOR THE SECOND REPORT. IT WAS REPORTED THAT A NASOGASTRIC TUBE LEAKED AFTER INSERTION. ADDITIONAL INFORMATION CONFIRMED THAT THE LEAK OCCURRED OUTSIDE OF THE PATIENT AND THE TUBE REQUIRED REMOVAL AND REPLACEMENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25718503 ↗
• MalfunctionJun 29, 2026Material Puncture/Hole

  IT WAS REPORTED THERE WERE HOLES IN THE TUBING. ADDITIONAL INFORMATION RECEIVED 11-JUN-2026 NOTED THE NASOGASTRIC TUBE WAS USED ON A PATIENT "AND WAS CAUGHT AS THE LINE WAS RUNNING AND SO THEY TURNED IT OFF AND SWITCHED THE TUBING OUT." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25656070 ↗
• MalfunctionJun 16, 2026Leak/Splash

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2026-00453 FOR THE SECOND REPORT. REFER TO 9611594-2026-00454 FOR THE THIRD REPORT. IT WAS REPORTED THE NASOGASTRIC TUBE LEAKING WHEN FLUSHED/PRIMED. THE LEAKING WAS FROM THE TOP OF THE TUBE. NO HISTORY OF CLOGGING. THE PATIENT REQUIRED AN ADDITIONAL REINSERTION. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519788 ↗
• MalfunctionJun 16, 2026Leak/Splash

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2026-00452 FOR THE FIRST REPORT. REFER TO 9611594-2026-00453 FOR THE SECOND REPORT. IT WAS REPORTED THE NASOGASTRIC TUBE LEAKING WHEN FLUSHED/PRIMED. THE LEAKING WAS FROM THE TOP OF THE TUBE. NO HISTORY OF CLOGGING. THE PATIENT REQUIRED AN ADDITIONAL REINSERTION. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519783 ↗
• MalfunctionJun 16, 2026Leak/Splash

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00452 FOR THE FIRST REPORT. REFER TO 9611594-2026-00454 FOR THE THIRD REPORT. IT WAS REPORTED THE NASOGASTRIC TUBE LEAKING WHEN FLUSHED/PRIMED. THE LEAKING WAS FROM THE TOP OF THE TUBE. NO HISTORY OF CLOGGING. THE PATIENT REQUIRED AN ADDITIONAL REINSERTION. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25518990 ↗
• MalfunctionJun 11, 2026Leak/Splash

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2026-00432 FOR THE FIRST REPORT REFER TO 9611594-2026-00433 FOR THE SECOND REPORT REFER TO . FOR THE THIRD REPORT. AN ADDITIONAL SAMPLE WAS RECEIVED FOR A COMPLAINT ABOUT A LEAKING NASOGASTRIC TUBE. NO ADDITIONAL INFORMATION PROVIDED. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25471937 ↗
• MalfunctionJun 11, 2026Complete Blockage; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A FEEDING TUBE BALLOONED/PUFFED DURING FLUSHING WHILE OCCLUDED, WITH THE AFFECTED SECTION LOCATED OUTSIDE THE PATIENT, AND THE TUBE WAS REMOVED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25471914 ↗
• MalfunctionJun 11, 2026Complete Blockage

  IT WAS REPORTED THAT A NASOGASTRIC (NG) TUBE BECAME CLOGGED DURING USE AND COULD NOT BE FLUSHED, REQUIRING REMOVAL OF THE TUBE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25471903 ↗
• MalfunctionJun 11, 2026Material Puncture/Hole

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT (B)(4) THE FOLLOWING: PATIENT PULLED OUT HER NG TUBE. A NEW SIZE 8 CORPAK NG TUBE WAS REPLACED, AND POSITION VERIFIED. WHEN RN WENT TO INSTILL FLUIDS, THERE SMALL HOLES NOTED AT THE TOP NG THE TUBE. TUBE REMOVED. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25471398 ↗
• MalfunctionJun 11, 2026Leak/Splash

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00432 FOR THE FIRST REPORT REFER TO . FOR THE SECOND REPORT REFER TO 9611594-2026-00434 FOR THE THIRD REPORT. AN ADDITIONAL SAMPLE WAS RECEIVED FOR A COMPLAINT ABOUT A LEAKING NASOGASTRIC TUBE. NO ADDITIONAL INFORMATION PROVIDED. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25471394 ↗
• MalfunctionJun 11, 2026Leak/Splash; Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2026-00433 FOR THE SECOND REPORT. REFER TO 9611594-2026-00434 FOR THE THIRD REPORT. IT WAS REPORTED THAT FORMULA LEAKED ON THE BED FROM THE NASOGASTRIC (NG) TUBE. THE NURSE WENT TO CHECK ON THE PATIENT WHEN SHE SAW THAT THERE WAS A HOLE IN THE DISTAL PART OF THE NG TUBING CLOSE TO THE CONNECTION OF THE NG PUMP TUBING WHERE FORMULA WAS COMING OUT. THE NG TUBE WAS TAKEN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25471379 ↗
• MalfunctionJun 4, 2026Complete Blockage; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A NURSE WENT TO FLUSH A NASOJEJUNAL (NJ) TUBE TO GIVE MEDICATIONS. HOWEVER, THE TUBE WOULD NOT FLUSH AND SEEMED CLOGGED. THE NURSE GAVE A LITTLE MORE PRESSURE TO SEE IF THAT WOULD UNCLOG, AND THE BOTTOM OF THE YELLOW TUBE (BY THE HUB OF THE NJ TUBE WHERE YOU SCREW ON FEEDS) BALLOONED OUT LIKE A URINARY CATHETER. TURNS OUT, THE PATIENT'S HAIR BOW WAS CAUSING THE NJ TO BE OCCLUDED. HOWEVER, WITH LITTLE TO MODERATE PRESSURE, THE NJ TUBE WAS FAULTY AND BECAME DEFECTIVE AND NOT USEABLE. AFTER BALLOONING OUT, THE NJ TUBE AT THE END WAS STRETCHED AND THIN. THEY TAPED IT TO KEEP IT STRAIGHT SO IT WOULDN'T BEND AND BREAK. THEN A COUPLE HOURS LATER A NEW NJ HAD TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399092 ↗
• MalfunctionMay 26, 2026Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT A NASOGASTRIC TUBE WAS LEAKING WHERE THE YELLOW TUBING MEETS THE CLEAR BIFURCATE. THERE WERE VISIBLE HOLES IN THE TUBING. THE TUBE HAD TO BE REPLACED. EVENT DATE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279126 ↗
• MalfunctionMay 18, 2026Complete Blockage

  IT WAS REPORTED THAT A NASOGASTRIC FEEDING TUBE WAS BLOCKED AND THE FLUID DIDN¿T FLOW THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204469 ↗
• MalfunctionMay 13, 2026Complete Blockage

  IT WAS REPORTED THERE WAS AN ISSUE WITH A 6FR AVANOS NGT (NASOGASTRIC) WHERE THE DISTAL END/GASTRIC TIP OF THE NGT (OPENING INTO THE STOMACH) WAS COMPLETELY CLOSED OVER (NO HOLE FORMED DURING MANUFACTURING) WHICH MEANT THAT AFTER INSERTION THE NGT WAS UNABLE TO BE FLUSHED OR ASPIRATED. ADDITIONAL INFORMATION RECEIVED 15-APR-2026 STATED "UNFORTUNATELY THE ISSUE WAS FOUND POST TUBE INSERTION. INITIALLY NOTICED DIFFICULTY TRYING TO REMOVE THE STYLET DESPITE PRE-FLUSHING WITH WATER, THEN WERE UNABLE OBTAIN A GASTRIC ASPIRATE TO CONFIRM TUBE POSITION. NOTED RESISTANCE "[INCREASINGLY]" WHEN TRYING TO OBTAIN A GASTRIC ASPIRATE. A DECISION WAS MADE TO REMOVE THE NGT AS IT WAS ASSUMED TO BE FAULTY AND THEN WE INSERTED A NEW ONE FOR THE PATIENT. UPON REMOVAL, IT WAS NOTICED THE NGT WAS UNABLE TO BE FLUSHED WITH WATER AND THAT¿S WHEN WE NOTICED THERE WAS NO OPENING FORMED AT THE DISTAL END/GASTRIC TIP OF THE NGT. THE USER "EXAMINED THE REST OF OUR TUBE STOCK AND FOUND ONE OTHER NGT THAT HAD A PARTIALLY FORMED OPENING (FROM THE SAME BATCH NUMBER)." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165125 ↗
• MalfunctionMay 13, 2026Fracture

  IT WAS REPORTED THE NASOGASTRIC TUBE "RIPPED WHILE USING." DATE OF EVENT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161721 ↗
• MalfunctionMay 12, 2026Break; Burst Container or Vessel; Difficult to Flush; Material Split, Cut or Torn

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2026-00313 FOR THE FIRST EVENT. REFER TO 9611594-2026-00314 FOR THE SECOND EVENT. IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 22827357 THE FOLLOWING: EVENT OR PROBLEM DESCRIPTION THE NASOGASTRIC TUBE "BURST WHILE BEING INSIDE THIS PATIENT. RNS ARE PROPERLY FLUSHING TUBE BETWEEN MEDS AND PRIOR TO/AFTER MEDICATION ADMINISTRATION."

  Patient problems: Insufficient Information

  MAUDE report 25156666 ↗
• MalfunctionMay 12, 2026Break; Burst Container or Vessel; Difficult to Flush; Material Split, Cut or Torn

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00313 FOR THE FIRST EVENT. REFER TO 9611594-2026-00315 FOR THE THIRD EVENT. IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 22827357 THE FOLLOWING: EVENT OR PROBLEM DESCRIPTION THE NASOGASTRIC TUBE "BURST WHILE BEING INSIDE THIS PATIENT. RNS ARE PROPERLY FLUSHING TUBE BETWEEN MEDS AND PRIOR TO/AFTER MEDICATION ADMINISTRATION."

  Patient problems: Insufficient Information

  MAUDE report 25156656 ↗
• MalfunctionApr 24, 2026Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO FOR THE SECOND EVENT. IT WAS REPORTED "THE ITEM BREAKS VERY EASILY, THIS HAS NEVER HAPPENED BEFORE. THERE IS A LITTLE PRONG THAT CAME DISLODGED AND PATIENT IS NOT ABLE TO RECONNECT.¿ THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987926 ↗