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

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

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

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

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.
Category
Medical Device — Devices

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.

Related recalls

Same category