Z-0798-05

MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages

Name: Z-0798-05 MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages
Creator: U.S. Filter/Ionpure, Inc.
Published: 2005-02-28
License: https://open.fda.gov/license/

U.S. Filter/Ionpure, Inc. / initiated 2005-02-28 / Terminated

FDA source

U.S. Filter/Ionpure, Inc. began a recall of MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages on 2005-02-28. The reason FDA records is "Incorrect type of stainless steel firm used 303 vs 316". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0798-05
Status: Terminated
Initiated: 2005-02-28
Posted: 2005-05-06
Terminated: 2012-05-15
Recalling firm: U.S. Filter/Ionpure, Inc.
Product: MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages
Product code: FIP Subsystem, Water Purification
Reason for recall: Incorrect type of stainless steel firm used 303 vs 316
FDA 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 in commerce: 282 units
Distribution: Nationwide Foreign: Canada, Mexico
Product codes and lots: Models: MRORXO1, MRORXO2, MRORXO3,MRORXO4, MRORXO5, MRORXO6, MRORXO8,MRORXO9, MRORX12. CMRORX01, CMRORX02, CMRORX03, CMRORX04, CMRORX05, CMRORX08 Serial Numbers: 53130 through 60754 (not consecutive)

Product code FIP

K030652Class IIMedro SpdUsfilter/Ionpure, Inc. / cleared 2003-09-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)