Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tego Connector: REF: 011-D1000 Recalled by ICU Medical, Inc. Due to Needle free access device intended as accessory to...

Date: December 19, 2025
Company: ICU Medical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.

Affected Products

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

Quantity: 14,684,607 items

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ICU Medical, Inc.

ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report