Z-3087-2026Class II

5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

Name: Z-3087-2026 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2026-08-10
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2026-08-10 / Open, Classified

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 on 2026-08-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3087-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-10
Posted: 2026-09-02
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Product code: KOC Accessories, Blood Circuit, Hemodialysis
Reason for recall: 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.
FDA root cause: Component change control
Action: 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.
Quantity in commerce: 6,624 units
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.
Product codes and lots: Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3087-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3084-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-02
Z-3085-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-02
Z-3086-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-02
Z-3087-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-02

Product code KOC

K243505Class II5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC / cleared 2025-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)