CLASS II ONGOING Device recall · Reported 9 Sep 2026 · FDA Enforcement Report

5008X Standard HD Pre-Flush Standard Blood Tubing Set recalled

Fresenius Medical Care Renal Therapies Group is recalling 5008X Standard HD Pre-Flush Standard Blood Tubing Set, distributed nationwide in the US. The recall was initiated on 10 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 25KR01227 25NR01257 UDI-DI 00840861102556

Quantity recalled120 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3084-2026
FDA event ID: 99556
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Aug 2026
FDA classified: 2 Sep 2026
Reported: 9 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

10 Aug 2026	Recall initiated by company
2 Sep 2026	Classified by FDA	+23 days
9 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6

Where it was distributed

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.

Nationwide Alabama California Colorado Florida Georgia Illinois Kentucky Louisiana Massachusetts Maryland Minnesota Missouri North Carolina New Hampshire New York Ohio Pennsylvania Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lots 25KR01227 25NR01257 UDI-DI 00840861102556

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 99556

This product is part of a recall event; the main page for the event is 5008X HD/HDF with Twister Blood Tubing Set recalled.

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026	CLASS II	5008X HD/HDF with Twister Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026	CLASS II	5008X HD/HDF Standard Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026	CLASS II	5008X HD/HDF with CLiC Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide

More recalls from Fresenius Medical Care Renal Therapies Group

All 34

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	5008X HD/HDF with CLiC Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	5008X HD/HDF Standard Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Citrasate, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	NaturaLyte, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	Granuflo Dry Acid Concentrate: Product Numbers: 0FD2251-3B recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide

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All 13,778

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16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide