Bicarby" Dialysate — Class II medical device recall Z-2321-2026
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2026-06-17, distributed nationwide. Given the increased number of leaks reported by users, it was determined to be the appropriate course of actio
| Recall number | Z-2321-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2026-05-12 |
| Classified | 2026-06-05 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,756,108 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00840861102822, 00840861102839, 00840861102846, 00840861102853, 00840861102914, 00840861102945 |
| Lot numbers | 26AG02019 |
| Model numbers | RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, RFP-456-G |
Product
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Reason for recall
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
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-2321-2026. 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.