Fresenius Medical Care Renal Therapies Group, LLC recalls 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

On 8/10/2026, the firm began notifying consignees via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to 1. Identify any affected product on hand. 2. IMMEDIATELY segregate and discontinue use of affected lot. 3. Contact the call center at 1-888-943-4901 and reference Event 8514, between 8:00 AM 4:30 PM Eastern daily, for return of affected lots and replacement of your stock. 4, Complete and return the included reply form.

• FDA enforcement recordOfficial FDA database entry for Z-3087-2026
• FDA 510(k) clearance · K243505The device's official FDA premarket clearance record
• FDA device classification · KOCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5820The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Fresenius Medical Care Renal Therapies Group, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.