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FDA-Device2026-01-28Class IIPROCESSING DEFECT

ICU Medical Tego Connector recalled for defective silicone seal risking therapy delays

ICU Medical
OTHERNationwide distribution

Stop using ICU Medical Tego Connectors

ICU Medical's Tego Connector needle-free access devices have a silicone seal that may bulge, separate, or tear. This defect can cause fluid leaks, blockages, inability to draw or inject medication, and potential exposure to contamination or air in the bloodstream during hemodialysis or IV therapy.

  • Check the lot number on your device against the FDA recall list
  • Stop using affected Tego Connectors immediately
  • Contact your healthcare provider or dialysis center about replacement devices
  • Do not discard—return the device to your supplier for proper handling
Hazard

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

Sold states
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, ND, CO and the countries of BE, DE, CO, ES, AU, AR, SA, SI, IT, LK, MY, AT, FI, GB, TW, MX, NL, IE, CA, GR, ZA, SE, SK, NZ, LT, CH, HR, FR, JO, PE, SG, BR, PL, RO, HU, CZ, NO, AE, EE, CN, MA, HK.
Affected count
14,684,607 items
Manufactured in
951 Calle Amanecer, San Clemente, CA, United States
Products
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1111-2026

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