The Recall Desk
Severity pendingFDA (Devices)·Z-1111-2026·Announced 2026-01-28

Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

Pending LLM rewrite. Source: FDA_DEVICE Z-1111-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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

The recalled product

Product
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Manufacturer
ICU Medical, Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI-DI: 00840619026059
  • 00840619006785. REF/Lot(Expiration): 011-D1000/14015455(5/1/2029)
  • 14044313(6/1/2029)
  • 14228823(12/1/2029)
  • 14274294(1/1/2030)
  • 01C-D1000/14171414(10/1/2029)
  • 14304670(2/1/2030)
  • 055-D1000/13772668(9/1/2028)
  • 13778926(9/1/2028)
  • 13791786(10/1/2028)
  • 13794986(10/1/2028)
  • 13797963(10/1/2028)
  • 13801102(10/1/2028)
  • 13806764(10/1/2028)
  • 13812991(11/1/2028)
  • 13822705(11/1/2028)
  • 13828556(11/1/2028)
  • 13833879(11/1/2028)
  • 13838937(12/1/2028)
  • 13867515(1/1/2029)

Distribution

Distributed nationwide across the United States.