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

Needle free access connectors recalled over silicone seals that may tear

ICU Medical is recalling 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the body or tear, which can cause fluid leaks, occluded flow or air infused into the body.

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: Scored 3 under the risk-of-harm criterion: the firm states the defect may lead to exposure to biological contaminants and air infused into the body, and no injuries are reported.

Plain-English summary

The Tego Connector, REF 011-D1000, 01C-D1000, 055-D1000 and D1000, and the Conector Tego, REF LAT-D1000, are being recalled by ICU Medical, Inc.

The record states the needle free access device, intended as an accessory to vascular access used in hemodialysis or as an accessory to intravascular administration sets, has a silicone seal which may bulge at the top, separate from the body, or tear. The record states this may result in fluid leaks, occluded fluid flow, inability to inject or withdraw blood product, delayed or interrupted therapy, exposure to biological contaminants, and air infused into the body.

The record lists 14,684,607 items under UDI-DI 00840619026059 and 00840619006785, with REF, lot and expiration details recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow ICU Medical's instructions.

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 — Vascular access
Hazard
Affected units
14,684,607

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.

The notice also names 46 states specifically:

Related recalls

Same manufacturer · ICU Medical, Inc.

See all →

Same hazard · seal failure

See all →