Data Foundry

Medical device recalls 2025

Citric Complete — Class II medical device recall Z-0820-2025

Ongoing recall by Nipro Renal Soultions USA, Corporation, reported 2025-01-15, distributed in AZ, FL, GA, IL, MI, NC, NJ, OH…. The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

Recall numberZ-0820-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmNipro Renal Soultions USA, Corporation, Lewisberry, PA, United States
Recall initiated2024-11-22
Classified2025-01-08
Reported by FDA2025-01-15
DistributedAZ, FL, GA, IL, MI, NC, NJ, OH, TN, TX
Quantity2,810 units
Reason classeslabeling
Lot numbersNDC4F001, NDC4G006, NDC4H009, NDC4H010

Product

Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25

Reason for recall

The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

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-0820-2025. 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.