Fresenius Medical Care Renal Therapies Group, LLC recalls NaturaLyte

Complaints of blue-green discoloration in product

NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis

Fresenius Medical Care issued an URGENT MEDICAL DEVICE RECALL to its consignees on 7/15/2026 via USPS first class mail. The notice explained the issue, potential risk and requested the following action: "1. Identify if you have any affected product lots on hand. 2. IMMEDIATELY segregate and discontinue use of affected lots. 3. Contact FMCRTG (1-833-203-5448) between 8:00 AM 8:00 PM Eastern daily, for return of affected lots and replacement of your stock. 4. Complete and return the attached REPLY FORM." For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.

• FDA enforcement recordOfficial FDA database entry for Z-3092-2026
• FDA 510(k) clearance · K192017The device's official FDA premarket clearance record
• FDA 510(k) clearance · K212620The device's official FDA premarket clearance record
• FDA device classification · KPOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5820The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fresenius Medical Care Renal Therapies Group, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.