Salem Sump 8888266122 (UDI 10192253012804)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253012804), received between Jan 7, 2026 and May 14, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. Jul 24, 2024Class IIOpen, Classified

   The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

   Z-3302-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Break

  THE CUSTOMER REPORTED THAT DURING AN ATTEMPT TO REMOVE THE PLUG FROM THE NG TUBE IN ORDER TO RECONNECT IT TO SUCTION, THE PLUG BROKE AND BECAME STUCK INSIDE THE TUBE. AS A RESULT, THE NG TUBE COULD NOT BE RECONNECTED TO SUCTION. ATTEMPTS WERE MADE TO REMOVE THE BROKEN PLUG; HOWEVER, THE PIECES CAME OUT IN FRAGMENTS AND PART OF THE PLUG REMAINED LODGED INSIDE THE TUBE. THE TUBE WAS THEREFORE UNABLE TO BE USED FOR SUCTION. FURTHER ASSISTANCE WAS REQUIRED TO ADDRESS THE ISSUE. THE CUSTOMER STATED THAT THE PLUG THAT COMES WITH THE TUBING APPEARED TO BE THE ISSUE. THEY ALSO HAVE SEPARATE PLUGS AVAILABLE, AND WHEN THEY USED ONE OF THOSE, IT DETACHED EASILY WITHOUT ANY PROBLEMS. ADDITIONAL INFORMATION RECEIVED ON 13MAY2026 CONFIRMED THAT THE ISSUE WAS WITH THE ARV VALVE. THEY CANNOT CONFIRM THE REPORTED LOT NUMBER AS THE STAFF PROVIDED THE NUMBERS THAT THEY HAD AT THE TIME. THEY DIDN¿T HAVE TO INSERT ANOTHER TUBE, BUT THE PATIENT WAS QUITE ANXIOUS WHEN THEY INITIALLY COULDN¿T REMOVE IT. STAFF ASSISTED BY APPLYING COUNTER PRESSURE WHILE TWO PEOPLE ATTEMPTED TO REMOVE IT, BUT IT WOULDN¿T BUDGE. THEY THEN CALLED ANOTHER PERSON IN TO STABILIZE THE TUBE AT THE PATIENT¿S NOSE TO ENSURE THEY DID

  Patient problems: Anxiety

  MAUDE report 25173032 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED AT 2100H THE WRITER WENT TO CHECK THE PATIENT WITH THE NIGHT DOSE OF MEDICATION AND THE PATIENT WAS FOUND TO HAVE A LOT OF SPUTUM AROUND HER MOUTH AND SHE WAS SEMI RESPONSIVE. THE WRITER DID ORAL SUCTION AND CHECKED THE PATIENTS' VITAL SIGNS. THE RAPID RESPONSE TEAM WAS INITIATED. PATIENT'S GCS DECREASED TO 12. PATIENT'S BLOOD PRESSURE WAS 79/30MMHG, HEART RATE WAS 166, TEMPERATURE WAS 39.7. TYMPANIC. DR. (B)(6) WAS INFORMED ABOUT THE PATIENT'S HEALTH STATUS. AT 2110H THE PATIENT WAS HANDED OVER TO THE RAPID RESPONSE TEAM. DR. (B)(6) ARRIVED AT 2140H. ECG, CHEST X-RAY, BLOOD TEST, IV LINES, VASOPRESSORS, MEDICATION, AND A FOLEY CATHETER WAS INSERTED BY RAPID RESPONSE TEAM. AFTER INTERVENTION AND TREATMENT, MD DECIDED TO SEND THE PATIENT TO THE ICU. BASED ON ALL AVAILABLE INFORMATION, THERE IS NO ALLEGATION OF A PRODUCT MALFUNCTION AT THIS TIME. MULTIPLE GOOD FAITH EFFORTS HAVE BEEN MADE TO REQUEST ADDITIONAL INFORMATION FROM THE REPORTER. HOWEVER, TO DATE A RESPONSE HAS NOT YET BEEN RECEIVED.

  Patient problems: Fever; Low Blood Pressure/ Hypotension; Pneumonia; Tachycardia

  MAUDE report 23995577 ↗