⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a
very recent recall may be missing. Everything shown is accurate as of the last checked time on this page —
for anything time-critical, confirm with the official sources linked below.
FDAClass II · Medical device · Recalled June 17, 2026
Bicarby" Dialysate recall — Fresenius Medical Care Holdings, Inc.
Hazard: 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.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2321-2026
- Brand
- Fresenius Medical Care Holdings
- Classification
- Class II
- Units affected
- 1,756,108 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Affected products
Companies & origin
- Recalling firm location
- Waltham, MA, United States
- Firm address
- 920 Winter St Bld 920, N/A, 02451-1521
Identifying details (verbatim from the notice)
- Product codes / lots
- Model Number: RFP-400-G; UDI-DI: 00840861102839; 2. Model Number: RFP-401-G; UDI-DI: 00840861102853; 3. Model Number: RFP-402-G; UDI-DI: 00840861102822; 4. Model Number: RFP-404-G; UDI-DI: 00840861102914; 5. Model Number: RFP-407-G; UDI-DI: 00840861102846: 6. Model Number: RFP-456-G; UDI-DI: 00840861102945; All lots produced from January 13, 2025, through lot 26AG02019 on January 13, 2026
- Distribution
- US Nationwide distribution in the states of NY, TN and TX.
- Firm notified the public via
- Letter
- FDA event ID
- 98877
- Recall initiated
- May 12, 2026
- FDA classified
- June 5, 2026
- FDA report date
- June 17, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 2:00 AM UTC.
Report a data error on this page