CARDINAL HEALTH 8888266130ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10192253012835), received between Jun 9, 2025 and Sep 15, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 18, 2025Class IIOpen, Classified

   Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

   Z-0206-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Separation Failure

  The customer reported it is very hard to pull the top off. The anti-reflux valve is frequently extremely tight. Even opening a new tube, the reflux valve is very tight straight out of the package. They're able to get it out, but have to pull on it pretty hard with both hands before it releases. This is not great for replacing the valve when the tube is in someone's nose. Even new out of the package it is still quite difficult to remove the anti-reflux valve. This is a little different from what it has been like for the last couple years. Twisting, pulling, wiggling... it is all difficult and takes a fair amount of force. The reporter states they are not the only person who has resorted to cutting the blue lumen in order to put a new valve in. Very frequently, it is difficult enough to remove the valve that they have been nervous about hurting the patient or dislodging the tube.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774661 ↗
• MalfunctionJun 22, 2026Break

  THE CUSTOMER REPORTED WHILE UNCLAMPING THE TUBE, THE VALVE SNAPPED IN HALF AND WAS LODGED IN THE TUBE. RN WAS ABLE TO UNCLOG THE TUBE BY REMOVING THE BROKEN PIECE OF THE VALVE FROM WITHIN THE TUBE USING HEMOSTATS. NO HARM TO THE PATIENT, VALVE REPLACED BY OPENING A NEW PACKAGE. THE ITEM WAS PLACED IN THE PATIENT 6/14 AND REMOVED ON 6/16. UNFORTUNATELY THE ITEM WAS NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25577001 ↗
• MalfunctionJan 28, 2026Break; Separation Failure

  THE CUSTOMER REPORTED IT IS DIFFICULT TO PULL THINGS OUT OF THE TUBE (THE PURPLE CAP OR THE PIECE TO CONNECT TO THE SUCTION TUBE). THEY'VE GOTTEN STUCK OR BROKEN. AND PER SURGERY, THEY SUSPECT THE AIR FILTER PIECE IS NOT ALLOWING EFFECTIVE SUCTION. PER THEIR CARDINAL HEALTH SALES REPRESENTATIVE, THEY WENT ONSITE TO ADDRESS THE ISSUE AND OPENED UP ONE OF THE CUSTOMER'S SALEM SUMPS AND THEY PHYSICALLY COULD NOT REMOVE THE ARV FROM THE BLUE VENT LUMEN. THEY TRIED TWISTING, PULLING, AND WIGGLING IT TO TRY TO FREE IT UP. THERE WAS NOTHING THEY COULD DO TO GET IT REMOVED. PER THE SALES REPRESENTATIVE, THEY ALSO TRIED ANOTHER SALEM SUMP FROM THEIR OWN INVENTORY AND THE SAME ISSUE OCCURRED. THIS IS A MAJOR ISSUE FOR HEALTHCARE WORKERS WHO ARE TRYING TO PROPERLY VENT AND PREVENT AIR WHEN TRANSPORTING PATIENTS. PER ADDITIONAL INFORMATION PROVIDED THE ISSUE IS WIDESPREAD AT THE MOMENT. EVERY SALEM THE CUSTOMER PULLS OUT OF THE PACKAGE THEY FIND THEY ARE HAVING AN INCREDIBLY HARD TIME GETTING THE ARV OUT, IF AT ALL. THEY ACTUALLY BROKE ONE TRYING TO GET IT OUT OF THE TUBE BECAUSE THEY TRIED TO USE PLYERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203287 ↗
• MalfunctionDec 1, 2025Break; Break

  THE CUSTOMER REPORTED THEY WERE TESTING A NEW TUBE FROM THEIR UNIT 19 STORES CART AND THE ARV BROKE AT THE BLUE PART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23683661 ↗
• MalfunctionNov 20, 2025Break; Break

  THE CUSTOMER REPORTED THEY WERE TESTING AN OLD TUBE KEPT IN THEIR CNE OFFICE FOR TEACHING AND THE ARV BROKE AT THE BLUE PART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610358 ↗
• MalfunctionJun 23, 2025Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT THE ANTI REFLUX VALVE IS STUCK IN THE BLUE PORT AND WILL NOT COME OUT HOWEVER, PRIOR TO SENDING THE SAMPLE FOR EVALUATION, ONE OF THE CENTRAL SUPPLY FOLKS WAS ABLE TO FORCEFULLY REMOVE THE ARV BUT THE NURSES COULD NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309637 ↗
• MalfunctionJun 9, 2025Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT THE ANTI REFLUX VALVE IS STUCK IN THE BLUE PORT AND WILL NOT COME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168365 ↗