Karl Storz Endoscopy recalls Flexible Hystero-Fiberscope Kits REF: 11264BBU1

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.

On 5/21/2026, correction notices were emailed to customers who were asked to do the following: 1) Check the expiration date for any inventory of 26153EAU-01 Sealing Seal for Gynecology and discard any expired components(seals) by removing the seal from the packaging and discarding the seal and packaging. 2) Pass on this Urgent Medical Device Correction to all users of affected products and all other persons who need to be aware within your organization. 3) If you have or may have distributed the products listed, please identify and promptly notify those recipients with a copy of this notice and response form. 4) Completed and return the Customer Reply Form via email to KSEAProductLabeling@karlstorz.com For all other questions regarding this communication, please send an email to KSEAProductLabeling@karlstorz.com.

• FDA enforcement recordOfficial FDA database entry for Z-2794-2026
• FDA 510(k) clearance · K961605The device's official FDA premarket clearance record
• FDA device classification · HIHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 884.1690The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Karl Storz EndoscopySearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.