Salem Sump 8888266197 (UDI 10192253012866)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10192253012866), received between Aug 28, 2024 and Apr 7, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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-0209-2026 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Break

  THE CUSTOMER REPORTED THE SALEM SUMP ANTI-REFLUX VALVE BROKE IN HALF WITH THE BLUE PORTION TRAPPED IN THE PATIENT'S NASOGASTRIC TUBE AND HAD TO BE REMOVED WITH A KELLY CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24806284 ↗
• MalfunctionMar 9, 2026Break; Separation Failure

  THE CUSTOMER REPORTED THE CONCERN IS THAT THE ANTI-REFLUX VALVE EASILY BREAKS OR BECOMES LODGED IN THE NG TUBE. PER THE CUSTOMER, IF IT GETS STUCK IN THE TUBE, THE CONTENTS FROM THE BROKEN VALVE COULD POTENTIALLY ENTER THE PATIENT'S STOMACH. IT HAS OCCURRED ON THEIR UNIT SEVERAL TIMES WHERE IT BREAKS. PER ADDITIONAL INFORMATION PROVIDED ON MARCH 06, 2026 THE ISSUE IS OCCURRING DURING PATIENT USE. THERE HAVE BEEN OCCASIONS WHEN NURSING STAFF ATTEMPTED TO REMOVE THE ARV, AND IT BROKE OFF INSIDE THE TUBE. IN SOME CASES, THE ENTIRE TUBE HAD TO BE REPLACED. OTHER TIMES THE ARV WAS REMOVED, BUT IT REQUIRED SIGNIFICANT FORCE. THEY AREN'T ABLE TO PROVIDE SPECIFIC DETAILS OF EACH INCIDENT THAT HAS OCCURRED AS THEY WERE NOT DOCUMENTED, IT WAS ONLY MENTIONED TO THEM DURING THEIR STAFF HUDDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545142 ↗
• MalfunctionSep 3, 2025Separation Failure; Separation Failure

  THE CUSTOMER REPORTED THEY RECENTLY SWITCHED TO THESE ARVS AND ARE HAVING ISSUES WITH THE DEVICE GETTING STUCK TO THE NG TUBE. ARV CONNECTED BLUE SIDE TO BLUE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952045 ↗
• MalfunctionAug 15, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE PRODUCT BROKE DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817755 ↗
• MalfunctionJun 19, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE SALEM SUMP ARV WAS GETTING LODGED INTO TUBE AND BREAKING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292820 ↗
• MalfunctionJun 19, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE SALEM SUMP ARV WAS GETTING LODGED INTO TUBE AND BREAKING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292407 ↗
• MalfunctionJun 10, 2025Break; Break

  THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO REMOVE THE ANTI-REFLUX VALVE ON THE END OF NG [NASOGASTRIC] TUBE. ATTEMPTED TO REMOVE WITH HEMOSTATS AND VALVE BROKE IN HALF. EVENTUALLY ABLE TO REMOVE AFTER VALVE BROKE INTO THREE PIECES. 20ML OF AIR INSTILLED INTO BLUE REFLUX VALVE PORT ON NG, AND ANTI-REFLUX VALVE REPLACED PER DIRECTIONS GIVEN ON THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180690 ↗
• MalfunctionJun 5, 2025Break; Difficult to Remove

  UNABLE TO REMOVE THE ANTI-REFLUX VALVE ON THE END OF NG [NASOGASTRIC] TUBE. ATTEMPTED TO REMOVE WITH HEMOSTATS AND VALVE BROKE IN HALF. EVENTUALLY ABLE TO REMOVE AFTER VALVE BROKE INTO THREE PIECES. 20ML OF AIR INSTILLED INTO BLUE REFLUX VALVE PORT ON NG, AND ANTI-REFLUX VALVE REPLACED PER DIRECTIONS GIVEN ON THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148735 ↗
• MalfunctionApr 3, 2025Break; Break

  THE CUSTOMER REPORTED THE SALEM SUMP ANTI-REFLUX VALVE SNAPPED IN HALF WHILE REMOVING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762738 ↗
• MalfunctionFeb 19, 2025Break; Break

  THE CUSTOMER REPORTED THE VALVES ARE BREAKING IN THE NG TUBE AND HAVE TO BE RETRIEVED/PULLED OUT WITH HEMOSTATS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411718 ↗
• MalfunctionJan 16, 2025Break; Break

  THE CUSTOMER REPORTED THE ANTI-REFLUX VALVE (ARV) USED FOR NG TUBES ARE NOTED TO BE MORE FRAGILE AND BREAKING APART. THIS HAS BEEN NOTED ON MULTIPLE UNITS. THE VALVES BECOME WEDGED IN THE BLUE TUBING OF THE NGS AND ARE ALMOST IMPOSSIBLE TO REPLACE WHEN THEY BREAK AT THE WEAK POINT (JUST BELOW THE DISK AT THE MIDPOINT). PER ADDITIONAL INFORMATION PROVIDED BY THE REPORTER ON 27JAN2025, THE ARVS WERE REMOVED FROM THE NG TUBES AND REPLACED WITH A NEW ARV. ONCE THE VALVE BREAKS IT IS INCREDIBLY DIFFICULT TO REMOVE AND REPLACE THE BROKEN VALVE, STAFF HAS TO CUT THE BLUE TUBING IN ORDER TO ATTACH A NEW VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168177 ↗
• MalfunctionSep 13, 2024Break; Break

  THE CUSTOMER REPORTED THE ANTI-REFLUX VALVE WAS BEING INSERTED INTO A NASOGASTRIC TUBE AND SNAPPING AT THE MIDDLE OF THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216611 ↗
• MalfunctionAug 28, 2024Break; Break

  THE CUSTOMER REPORTED THE ANTI REFLUX VALVE SNAPPED AT THE BLUE AND WHITE PART. THIS WAS THEN REPLACED AND THE NEW ONE ALSO BROKE AT THE WHITE AND BLUE INTERSECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087674 ↗