5008X Blood Tubing Set — Class II medical device recall Z-2702-2026
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2026-07-15, distributed nationwide. Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to
| Recall number | Z-2702-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2026-05-11 |
| Classified | 2026-07-08 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00840861102518, 00840861102525, 00840861102532, 00840861102556 |
| Lot numbers | 26BR01177, 26BR01184, 26BR01185, 26BR01188, 26BR01189, 26BR01201, 26BR01202, 26BR01214, 26BR01215, 26BR01805, 26CR01003, 26CR01017, 26CR01018, 26CR01019, 26CR01020, 26CR01021, 26CR01025, 26CR01026, 26CR01027, 26CR01029, 26CR01034, 26CR01039, 26CR01040, 26CR01041, 26CR01043, 26CR01800, 26CR01803, 26CR01804, 26DR01077, 26DR01079, 26DR01080, 26DR01129, 26DR01130, 26DR01134, 26DR01150, 26DR01151 |
| Model numbers | 03-5110-6, 03-5300-3, 03-5300-3C, 03-5350-8, 5008X |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2702-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.