CARDINAL HEALTH 8888266122ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10192253012811), received between Jan 24, 2025 and Sep 15, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774379 ↗
• MalfunctionNov 20, 2025Break; Break

  THE CUSTOMER REPORTED THE ARV BROKE WHEN TRYING TO REMOVE IT WHEN ORDERED FOR THE NG TO DRAIN AFTER BEING CLAMPED. PER ADDITIONAL INFORMATION PROVIDED ON 17NOV2025, THE NG WAS CLAMPED AND THE WHITE PART OF THE ARV WAS IN THE SUCTION LUMEN, UPON ATTEMPT TO REMOVE IT TO REATTACH TO SUCTION, IT BROKE AT THE WHITE PART OF THE ARV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609796 ↗
• MalfunctionNov 20, 2025Break; Break

  THE CUSTOMER REPORTED THE ARV BROKE WHEN TRYING TO REMOVE IT WHEN ORDERED FOR THE NG TO DRAIN AFTER BEING CLAMPED. PER ADDITIONAL INFORMATION PROVIDED ON 17NOV2025, THE NG WAS CLAMPED AND THE WHITE PART OF THE ARV WAS IN THE SUCTION LUMEN, UPON ATTEMPT TO REMOVE IT TO REATTACH TO SUCTION IT BROKE AT THE BLUE PART OF THE ARV. THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW ONE HAS TO BE RE-INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609645 ↗
• MalfunctionJun 9, 2025Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT THE BLUE AND WHITE PIECE IS UNABLE TO BE REMOVED FROM TUBE. UNABLE TO USE ITEM DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169283 ↗
• MalfunctionJun 9, 2025Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT THE CAP WILL NOT COME OFF THE ANTI-REFLUX VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168114 ↗
• MalfunctionJun 9, 2025Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT THE SALEM SUMP ANTI-REFLUX VALVE WAS UNABLE TO BE REMOVED FROM THE BLUE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167498 ↗
• MalfunctionMay 8, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE BLUE/WHITE FILTERED PLUG END FOR NG TUBE PULLED APART AT THE WHITE END WITH WHITE PORTION STUCK IN TUBE. REMOVED WHITE PORTION WITH USE OF KELLY CLAMP. STILL ABLE TO UTILIZE NG. ADDITIONAL DETAILS ABOUT INCIDENT: WHEN THE FILTER/VALVE HAD BEEN ATTEMPTED TO BE REMOVED FROM THE TUBING IT HAD GOTTEN STUCK. MANUAL REMOVAL WAS UNSUCCESSFUL AND THE WHITE PORTION OF THE FILTER SNAPPED OFF. THE BLUE PORTION WAS ABLE TO BE REMOVED FROM THE TUBING WITH THE ASSIST OF A KELLY CLAMP. THE NG TUBING WAS UNAFFECTED AND DID NOT HAVE TO BE REPLACED, ONLY THE FILTER/VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21990404 ↗
• MalfunctionMar 5, 2025Separation Failure; Separation Failure

  THE CUSTOMER REPORTED THEY CAN'T REMOVE THE ARV FROM THE SALEM SUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526398 ↗
• MalfunctionJan 24, 2025Separation Failure; Separation Failure

  THE CUSTOMER REPORTED THEY HAD NO LUCK GETTING THE ANTI-REFUX VALVE OFF BY TWISTING, PULLING, ETC. THIS ISSUE OCCURRED STRAIGHT OUT OF THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233174 ↗