FDA Medical Device Recalls (openFDA)
U.S. Filter/Ionpure, Inc.: MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages
- Recall number
- Z-0798-05
- Recalling firm
- U.S. Filter/Ionpure, Inc.
- Product
- MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages
- Status
- Terminated
- Initiated
- 2005-02-28
- Posted
- 2005-05-06
- Terminated
- 2012-05-15
- Reason
- Incorrect type of stainless steel firm used 303 vs 316
- Root cause
- Other
- Action
- US Filter notified consignees by letter between 3/17 and 3/28/05 advising users of the recall.US Service will field correct and replace units.
- Quantity
- 282 units
- Distribution
- Nationwide Foreign: Canada, Mexico
- Lot, serial or model codes
- Models: MRORXO1, MRORXO2, MRORXO3,MRORXO4, MRORXO5, MRORXO6, MRORXO8,MRORXO9, MRORX12. CMRORX01, CMRORX02, CMRORX03, CMRORX04, CMRORX05, CMRORX08 Serial Numbers: 53130 through 60754 (not consecutive)
- 510(k) numbers
- ["K030652"]
- PMA numbers
- not on file
- Product code
- FIP
- Firm FEI
- 1000121072
- Firm city
- Lowell
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28