Data Foundry

Medical device recalls 2026

Citrasate — Class II medical device recall Z-3093-2026

Ongoing recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2026-09-09, distributed nationwide. Complaints of blue-green discoloration in product

Recall numberZ-3093-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmFresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States
Recall initiated2026-07-14
Classified2026-09-03
Reported by FDA2026-09-09
DistributedNationwide (US)
Countries outside the USMX
UPC / GTIN / UDI-DI00840861101344, 00840861101351, 00840861101375
Lot numbers26BXAC038, 26BXAC039, 26BXAC040, 26BXAC041

Product

Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis

Reason for recall

Complaints of blue-green discoloration in product

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3093-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.