Convenience kits used for dialysis maintenance Medline ADD A CATH… — Class II medical device recall Z-1465-2026
Ongoing recall by Medline Industries, LP, reported 2026-03-04, distributed nationwide. Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include si
| Recall number | Z-1465-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-01-08 |
| Classified | 2026-02-24 |
| Reported by FDA | 2026-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 14,525 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00653160368758, 00653160368925, 00653160374520, 00653160374971, 00653160375848, 00653160383478, 00653160383621, 10653160368755, 10653160368922, 10653160374527, 10653160374978, 10653160375845, 10653160383475, 10653160383628 |
| Lot numbers | 2024050790, 2024051390, 2024051490, 2024060690, 2024061780, 2024070180, 2024081280, 2024082290, 2024101690, 2024103190, 2024111290, 2024111990, 2024121390, 2025010890, 2025012490, 2025013090, 2025021290, 2025032090, 2025032690, 2025033190, 2025040190, 2025040401, 2025041090, 2025050190, 2025051390, 2025061790, 2025062790, 2025071490, 2025072190, 2025081401, 2025091090 |
Product
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741
Reason for recall
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
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-1465-2026. 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.