Use cautionMedical device recall · FDA · Published December 19, 2025
Tego Connector: Silicone seal may bulge, tear causing leaks or infection
ICU Medical recalls Tego Connectors with specific model numbers due to risk of silicone seal bulging, tearing, leading to fluid leaks, blood product injection issues, or exposure to contaminants during hemodialysis.
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
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Contact the company
📍Recalling firmICU Medical, Inc.951 Calle Amanecer · San Clemente, CA 92673-6212
✎ GovInfoNow plain-language explainer
ICU Medical recalls Tego Connectors (model numbers listed) because their silicone seal can bulge or tear, potentially causing fluid leaks, interrupted therapy, or exposure to biological contaminants. This affects medical devices used in hemodialysis or intravascular treatments. Read more at govinfonow.com/recall/50374-tego-connector-silicone-seal-may-bulge-tear-causing-leaks-or.
“Tego Connector: Silicone seal may bulge, tear causing leaks or infection.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50374-tego-connector-silicone-seal-may-bulge-tear-causing-leaks-or. Based on FDA recall #Z-1111-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1111-2026%22&limit=1).
ICU Medical, Inc. recalled Tego Connectors worldwide on Dec. 19, 2025, due to a silicone seal that may bulge or tear, according to the FDA. The hazard includes fluid leaks and potential exposure to biological contaminants.
How to tell if you have it
Brand: Tego
Product: Tego Connector (REF: 011-D1000, 01C-D1000, 055-D1000, D1000) and Conector Tego (REF: LAT-D1000)
Units affected: 14,684,607 items
The hazard
The needle-free access device has a silicone seal which may bulge at the top, separate from the body, or tear. This defect may result in fluid leaks, occluded fluid flow, inability to inject or withdraw blood products, delayed or interrupted therapy, exposure to biological contaminants, or air infused into the body.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Other recent recalls of similar products include Medline Kits with Tego Connectors May Have Damaged Silicone Seals (Jan. 8, 2026), Medline Apheresis Kits with Tego Connectors May Have Silicone Seal Issues (Jan. 8, 2026), and Medline Dialysis Kits with Tego Connectors May Have Seal Issues (Jan. 8, 2026).
How to tell if you have this one
Check for model numbers: 011-D1000, 01C-D1000, 055-D1000, D1000, or LAT-D1000. These connectors are used with hemodialysis or intravascular administration sets.
Brand
Tego
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for model numbers on the connector: 011-D1000, 01C-D1000, 055-D1000, D1000, or LAT-D1000.
Contact Manufacturer
Reach out to ICU Medical for guidance on next steps if you have a recalled connector.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 44 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including in the states of FL, AZ, RI, TN, KS, NJ, NY, VA, SC, GA, CA, MS, TX, OH, NC, MA, WA, IL, PA, NV, NH, LA, MI, NE, ME, MN, NM, OK, MD, IA, OR, SD, WI, MO, AL, WY, IN, KY, DC, UT, AR, WV, AK,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1111-2026 (December 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1111-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.