Salem Sump 266197 (REF 266197-)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884527022762), received between Jun 19, 2025 and Feb 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Break

  THE CUSTOMER REPORTED THIS PRODUCT HAS BEEN BREAKING OFF AT THE WHITE HALF WITH THE PERFORATED HOLES. THIS LEAVES THE BLUE HALF LODGED IN THE NG. THIS HALF IS ALMOST IMPOSSIBLE TO REMOVE UNLESS MANIPULATED WITH THE USE OF LARGE PLIERS AND SCISSORS, WHICH THEY WERE ABLE TO DO FOR THIS PATIENT. THIS DID CAUSE STRESS AND UNNECESSARY DISCOMFORT TO THE PATIENT. THIS IS NOT THE FIRST TIME THIS PRODUCT HAS BROKE WHILE IN USE WITH A PATIENT AND IT ALWAYS BREAKS AT THAT SAME SPOT.

  Patient problems: Anxiety; Discomfort

  MAUDE report 24274966 ↗
• MalfunctionFeb 5, 2026Break

  THE CUSTOMER REPORTED AN ONGOING ISSUE WITH THE SPIGOT SNAPPING ON THE WHITE PART WHEN TRYING TO REMOVE FROM NG TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24274952 ↗
• MalfunctionFeb 5, 2026Break

  THE CUSTOMER REPORTED THAT ONE OF THE ANTI REFLUX VALVES FROM THE LAST DELIVERY WAS BROKEN IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272234 ↗
• MalfunctionJul 7, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE ANTI REFLUX CAP HAS BROKEN IN HALF. PER CUSTOMER, THE NURSE WAS WITH THE PATIENT IN BED DURING THE INCIDENT, THE PATIENT DID NOT KNOW WHY THE CAP HAD BROKEN IN HALF. THE ISSUE WAS DETECTED DURING THE COMMISSIONING OF THE PRODUCT; THIS HAS HAD NO CONSEQUENCES FOR THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22430825 ↗
• MalfunctionJun 19, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE ANTI REFLUX CAP HAS ALREADY BROKEN IN HALF 2 TIMES. PER CUSTOMER, FIRST TIME, THE NURSE COULDN'T GET THE CAP OFF AND THEN IT BROKE IN HALF. SECOND TIME WAS IN BED WITH THE PATIENT, THE PATIENT DID NOT KNOW WHY IT HAD BROKEN IN HALF. THE ISSUE WAS DETECTED DURING THE COMMISSIONING OF THE PRODUCT; THIS HAS HAD NO CONSEQUENCES FOR THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292865 ↗