AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley… recallZ-2321-2012 · AmeriWater Inc · initiated Aug 9, 2012
Class II Terminated All recalls posted in September 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AmeriWater Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The firm, AmeriWater, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2012, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall; remove affected devices from service until the correction is completed to prevent malfunction of the device during patient treatment; and complete and return the attached response form to AmeriWater within 30 days via fax to 937/461-1988 Attn: Quality Assurance. AmeriWater dealer will be contacting their customers to schedule replacement of the fuses. If you have any questions, contact your local AmeriWater dealer or AmeriWater customer service at 1-800-535-5585.
Recall details
- Recall number
- Z-2321-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 9, 2012
- Posted by the FDA
- Sep 6, 2012
- Recalling firm
- AmeriWater Inc
- Quantity
- 80 Units
- Product code
- FIP
- FDA submissions
- K111740
- Distribution
- Worldwide distribution: USA (nationwide) including states of: AL, AR, CO, CT, FL, GA, IL, IN, KS, MA, MD, MO, MS, NC, NY, OH, OK, SC, TN, TX and VA; and country of: Canada.
Product description
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.
Code information (models, lots, serial numbers)
Model Number MROS, Catalog #00MROS20, 00MROS21 & Model Number MRO1, Catalog #00MRO120, and 00MRO121; Model Number(s): MROS and MRO1; Serial #'s 31000 to 31079.
Other devices under the same FDA submission
1 device cleared under K111740 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AmeriWater MROSAmeriwater, LLC · Subsystem, Water Purification1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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