Nephros DSU-H UltraFilter 70-0285Recalls & reported problems
Nephros, Inc. · The Nephros DSU-H UltraFilter is a disposable in-line water ultrafilter used to filter EPA quality drinking water. The filter retains bacteria, viruses, and endotoxin. By providing ultrapure water for washing and drinking, the filters aid in infection control. The filter produces water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00896241002381), received between Nov 26, 2025 and Nov 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Filtration Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Filtration Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2025Filtration Problem; Filtration Problem
ON 10/16/2025 IT WAS REPORTED THAT A HEALTHCARE FACILITY RECEIVED A POSITIVE CULTURE DOWNSTREAM OF A DSU-H (70-0285) IN ONE OF THEIR ICE MACHINES. THERE WERE NO REPORTED ADVERSE EVENTS. NEPHROS DSU-H IS AN IN-LINE WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED BEFORE ICE MACHINES IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA, VIRUS AND ENDOTOXIN. THE USER FACILITY ROUTINELY TEST THEIR WATER AT THEIR ICE MACHINE AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. A POSITIVE CULTURE CAN BE CAUSED BY AN IMPROPER DISINFECTION OF THE ICE MACHINE OR WATER LINES LEADING TO THE ICE MACHINE, AND/OR A BREACH OF THE FILTER MEMBRANE. THE ROOT CAUSE OF THE POSITIVE CULTURE COULD NOT BE CONFIRMED AS THE FILTER WAS NOT RETURNED FOR ADDITIONAL INVESTIGATION. COMPREHENSIVE REVIEW OF THE SPECIFIC FILTER DEVICE HISTORY RECORD AND MANUFACTURING INSPECTIONS DID NOT IDENTIFY ANY PRODUCT ISSUES INCLUDING DEVICE MALFUNCTION/DEFECT. ADDITIONAL INFORMATION INCLUDING RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23657689 ↗
Other System, Water Purification, General Medical Use devices
- DSU-H Quick Connect 70-0285Nephros, Inc. · System, Water Purification, General Medical Use4 reports
- S100 Sink Spout 70-0280Nephros, Inc. · System, Water Purification, General Medical Use2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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