Allon® 200-00263Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290107581103), received between May 3, 2020 and Nov 14, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fungus in Device Environment” (1 report).

1 other recall cover devices cleared under the same FDA submission (K024128); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionNov 14, 2025Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED BY THE USER THAT MOLD WAS DISCOVERED IN THE TANK OF AN ALLON UNIT USED IN ONE OF THEIR DEPARTMENTS. THE USER FURTHER STATED THAT THE DISTRIBUTOR HAD RECOMMENDED THE USE OF TAP WATER INSTEAD OF 0.22 MICRONS FILTERED WATER AS SPECIFIED IN THE MANUFACTURER'S INSTRUCTIONS FOR USE (IFU). THE USER INDICATED THAT THE PRESENCE OF MOLD IN THE TANK WAS CAUSED BY FOLLOWING THIS RECOMMENDATION, WHICH CONTRADICTS THE IFU REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555826 ↗
• MalfunctionJan 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING SITE VISIT, BELMONT'S CLINICAL SPECIALIST WAS INFORMED THAT THE PATIENT SUFFERED A BURN DURING USE WITH AN ALLON UNIT.

  Patient problems: Skin Tears

  MAUDE report 21071609 ↗
• MalfunctionJul 8, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE HOSPITAL BIOMED REPORTED THAT THE ALLON WAS CONSTANTLY ALARMING BUT WAS UNABLE TO IDENTIFY THE SPECIFIC ALARMS THAT THE SYSTEM WAS EXHIBITING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139621 ↗
• MalfunctionJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BELMONT MEDICAL TECHNOLOGIES RECEIVED AN INITIAL REPORT FROM THE HOSPITAL RISK MANAGEMENT/PATIENT SAFETY OFFICER THAT THE PATIENT POTENTIALLY SUSTAINED BURNS, LIMITED TO THE LEFT POSTERIOR ARM AND LEFT HIP/UPPER BUTTOCK AREA, WHICH REPORTEDLY DEVELOPED TWO DAYS AFTER SURGICAL TREATMENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12064092 ↗
• MalfunctionMay 3, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THERE WAS NO WATER FLOW WHILE USING THE ALLON.

  Patient problems: No Information

  MAUDE report 10019824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K024128. One submission often covers many models, so check the product and lot details in each record.

• Z-1966-2025 · May 13, 2025 · Open, Classified
  Allon 2001. Part Number: 200-00263