FDA-Device2026-01-28Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

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

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The agency's original wording

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

Intended for

Adults

Illnesses reported

None reported

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

More ICU Medical recalls

FDA-Device2026-07-22
ICU Medical Plum Solo Precision IV Pump v1.0.3 recalled for potential overdose risk
FDA-Device2026-07-22
ICU Medical Plum Duo Infusion Pump recalled for potential overdose risk

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