Class II
Medical Device Recall: Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Karl Storz Endoscopy · May 21, 2026
Reason for Recall
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
Distribution
US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.
States Affected
NATIONWIDE
Quantity Affected
45
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2794-2026
Status: ongoing
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