AmeriWater MROSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817927020000), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K111740); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Product Quality Problem; Product Quality Problem

  AMERIWATER IS SELF-REPORTING AN ISSUE EXPERIENCED WITH THE PENTAIR CHLROPLUS20 CARBON BLOCK FILTER USED AS PRETREATMENT FOR THE AMERIWATER MODEL MROS AND AMERIWATER CENTURION, MODEL MROC. ON (B)(6) 2025, AMERIWATER RECEIVED NOTICE FROM A LOCAL CUSTOMER THAT THE CARBON BLOCK FILTERS (AMERIWATER PART NUMBER: 20-5012) USED IN THE AMERIWATER MODEL MROS PORTABLE REVERSE OSMOSIS SYSTEM WERE EXPERIENCING PREMATURE CHLORINE BREAKTHROUGH. NO ADVERSE EVENTS, INJURY, ILLNESS, OR PATIENT EXPOSURE WAS REPORTED. THE PREMATURE CHLORINE BREAKTHROUGH WAS BELIEVED TO BE THE RESULT OF WATER CONDITIONS AT THE FACILITY. AMERIWATER REPLACED THE FILTERS AND RETURNED THE ALLEGEDLY NONCONFORMING FILTER CARTRIDGES TO OUR FACILITY FOR TESTING. CHLORINE BREAKTHROUGH WAS EXPERIENCED AFTER LESS THAN A WEEK OF USE, WHEN THE FILTER CAPACITY NORMALLY LASTED LONGER THAN 1 MONTH. ON (B)(6) 2025 AMERIWATER REPLACED THE NONCONFORMING FILTERS WITH FILTERS FROM A KNOWN GOOD LOT. 16-JAN-2025, A SECOND REPORT WAS RECEIVED FROM AN END USER IN (B)(6). NO ADVERSE EVENTS, INJURY, ILLNESS, OR PATIENT EXPOSURE WAS REPORTED. AMERIWATER HALTED SHIPMENT OF THE 20-5012 FILTERS, QUARANTINED THE FILTERS, AND BEGAN TESTING SAMPLES FRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379303 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111740. One submission often covers many models, so check the product and lot details in each record.

• Z-2321-2012 · Aug 9, 2012 · Terminated
  AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are wat