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5008X Blood Tubing Set, 24 units per case. Includes the… recallZ-2702-2026 · Fresenius Medical Care Holdings, Inc. · initiated May 11, 2026

Class II Open, Classified All recalls posted in July 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

FDA root cause category: Process control

What the company is doing

Fresenius Medical Care notified consignees on about 05/11/2026 via "IMPORTANT MEDICAL DEVICE INFORMATION" letter. Consignees were informed of the issue of potential Online Port Errors and additional information to support proper connection of the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. When pushing the substitution fluid connector (SafeLineTM) into the substitution fluid port, firmly insert the substitution fluid connector until you feel resistance. Check that there is no visible gap between the ring of the connector and the module. In the case of a visible gap between the ring of the connector and the module surface, apply pressure and push the connector to close the gap before automatic closure of the substitution fluid port door. Fresenius Medical Care is assessing improvements to restore the usual handling and user experience. FMCRTG is not requesting return of any product. ***Update*** On 06/292026, the firm sent a follow-up letter to consignees via First Class Mail. The updated letter states the firm has initiated shipments of limited quantities of new unaffected product. Customers are instructed to preferentially use unaffected lots of the tubing sets. If the customer needs to administer treatment and there are no alternatives available, they may use the affected lots of tubing sets to provide therapy, but only if they follow the specific instructions for using these affected sets. Unaffected lots of product do not require additional effort to seat the connector into the port. ***Update*** On 08/10/2026, the firm sent a follow up letter to consignees notifying them that product stock is available to replace affected products and the notification included specific lot numbers affected.

Recall details

Recall number
Z-2702-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
May 11, 2026
Posted by the FDA
Jul 8, 2026
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
113,544 units (4,731 cases)
Product code
KDI
FDA submissions
K243505
Distribution
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA.

Product description

5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 3. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 4. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Sets manufactured after February 26, 2026 1. Model Number: 03-5110-6; UDI-DI: 00840861102556; Lot Number: 26BR01177. 2. Model Number: 03-5300-3; UDI-DI: 00840861102518; Lot Numbers: 26BR01184, 26BR01202, 26CR01025, 26CR01039, 26CR01803, 26BR01185, 26BR01214, 26CR01026, 26CR01040, 26CR01804, 26BR01188, 26BR01215, 26CR01027, 26CR01041, 26DR01134, 26BR01189, 26BR01805, 26CR01029, 26CR01043, 26BR01201, 26CR01003, 26CR01034, 26CR01800. 3. Model Number: 03-5300-3C; UDI-DI: 00840861102532; Lot Numbers: 26CR01018, 26CR01020, 26DR01129, 26DR01150, 26CR01019, 26CR01021, 26DR01130, 26DR01151. 4. Model Number: 03-5350-8; UDI-DI: 00840861102525; Lot Numbers: 26CR01017, 26DR01077, 26DR01079, 26DR01080.

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K243505 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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