Tego Connector: REF: 011-D1000 — Class II medical device recall Z-1111-2026
Ongoing recall by ICU Medical, Inc., reported 2026-01-28, distributed nationwide. Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intrav
| Recall number | Z-1111-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2025-12-19 |
| Classified | 2026-01-16 |
| Reported by FDA | 2026-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 14,684,607 items |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00840619006785, 00840619026059 |
| Lot numbers | 1427429291 |
| Model numbers | 011-D1000, 01C-D1000, 055-D1000, D1000, LAT-D1000 |
Product
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Reason for recall
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, 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-1111-2026. 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.