Quick Facts at a Glance
- Recall Date
- May 7, 2026
- Hazard Level
- HIGH
- Brand
- Fresenius Medical Care Holdings
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Fresenius Medical Care Holdings
- Model numbers
- Model number: RFP-400-G, UDI-DI: 00840861102839, Lot codes: 25SG06026, 25SG06027
- Where affected
- TX
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 7, 2026
Reported by FDA DEVICE
June 17, 2026
RecallRadar source check
June 23, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fresenius Medical Care Holdings, Inc. or your healthcare provider for instructions. Notification method: Letter
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Full Description
Bicarby Dialysate; Model number: RFP-400-G;. Reason: There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.. Classification: Class II. Quantity: 4752. Distribution: Domestic: TX.
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Safety Guide
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