AmeriWater MRO Dialysis RO+ System — Class II medical device recall Z-2321-2012
Terminated recall by AmeriWater Inc, reported 2012-09-12, distributed nationwide. The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses in
| Recall number | Z-2321-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AmeriWater Inc, Dayton, OH, United States |
| Recall initiated | 2012-08-09 |
| Classified | 2012-09-06 |
| Reported by FDA | 2012-09-12 |
| Terminated | 2014-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 80 units |
| Reason classes | device malfunction |
| Serial numbers | 31000, 31079 |
| Model numbers | 00MRO120, 00MRO121, 00MROS20, 00MROS21, MRO1 |
Product
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 water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.
Reason for recall
The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2321-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.