FDA Device recall Z-1467-2026
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI110…
- FDA Device
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI110… 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-1467-2026 |
| 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
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845
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 | Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 UDI-DI (ea) 10193489111538 UDI-DI (case) 20193489111535 Kit lots 20240520…Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 UDI-DI (ea) 10193489111538 UDI-DI (case) 20193489111535 Kit lots 2024052090 2024072690 2024100390 2024121290 2025020490 2025041590 2025062790 2025090890 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 UDI-DI (ea) 10889942723508 UDI-DI (case) 40889942723509 Kit lots 2024051690 2024073190 2024092490 2024121190 2025020790 2025032790 2025052990 EBSI1596 UDI-DI (ea) 10653160357162 UDI-DI (case) 00653160357165 Kit lots 2024070190 2024082390 2024102390 2024121790 2025031090 2025040190 2025052790 2025072890 EBSI1781 UDI-DI (ea) 10653160379638 UDI-DI (case) 00653160379631 Kit lots 2024100490 2024123090 EBSI1812 UDI-DI (ea) 10653160386735 UDI-DI (case) 00653160386738 Kit lots 2025032190 2025052990 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 UDI-DI (ea) 10653160345343 UDI-DI (case) 00653160345346 Kit lots 2024050680 2024072980 2024090380 2024111290 2024121190 2025032890 2025061790 2025072390 Medline DIALYSIS/PHERESIS DRESSING |
|---|
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-1467-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.