Recall Z-2794-2026— Karl Storz Endoscopy

Name: FDA recall Z-2794-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Class II · Ongoing

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2026-05-21. It names one FDA 510(k) clearance: K961605. Product: Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.. Reason: 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..

Recalling firm: Karl Storz Endoscopy
Classification: Class II
Status: Ongoing
Initiated: 2026-05-21
Firm location: El Segundo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K961605 — KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPEKARL STORZ Endoscopy-America, Inc.·cleared 1996-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.