Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
ECMO Reinforced Dual Lumen Cannula Recalled by OriGen Biomedical, Inc. Due to Clamping the clear tube very close to the...
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 OriGen Biomedical, Inc. directly.
Affected Products
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Quantity: 66
Why Was This Recalled?
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Where Was This Sold?
This product was distributed to 33 states: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MS, MO, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WI, DC
About OriGen Biomedical, Inc.
OriGen Biomedical, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report