FDA Device recall Z-1464-2026
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
- FDA Device
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746 by Medline Industries, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1464-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-08 |
| Published | 2026-03-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Reason
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.
Identifiers
| code_info | UDI-DI (ea) 10653160373582 UDI-DI (case) 00653160373585 Kit lots 2024051380 2024052080 2024052180 2024052280 2024071580 2025061790 2025072990 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1464-2026%22
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