Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
FDA Recall Z-2794-2026 · Posted 2026-07-23
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Recalling FirmKarl Storz Endoscopy
Recall StatusOpen, Classified
Product CodeHIH
Date Initiated2026-05-21
Product Quantity45
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.
Firm Action
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 [email protected]
For all other questions regarding this communication, please send an email to
[email protected].
Root Cause
Packaging change control
Distribution Pattern
US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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