B. Braun Medical Inc. received FDA Class I designation for an Urgent Medical Device Correction on April 22, 2026, affecting six Streamline Airless System and B3 Low Volume Hemodialysis Bloodline models. FDA identified this as the most serious recall type — the device may cause serious injury or death if used without correction. The recall stems from a tubing resin change causing air bubbles to adhere to arterial bloodlines during treatment, with bubble formation beginning approximately 60 minutes into dialysis. As of March 20, 2026, B. Braun has not reported any serious injuries or deaths. FDA instructs affected customers to use alternate dialysis equipment when available and follow mitigation protocols when no alternative exists.