Flexible Hystero-Fiberscope Kits REF: 11264BBU1… recallZ-2794-2026 · Karl Storz Endoscopy · initiated May 21, 2026

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Karl Storz Endoscopy or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Packaging change control

What the company is doing

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].

Recall details

Recall number: Z-2794-2026
Status: Open, Classified
Initiated by the company: May 21, 2026
Posted by the FDA: Jul 23, 2026
Recalling firm: Karl Storz Endoscopy
Quantity: 45
Product code: HIH
FDA submissions: K961605
Distribution: US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.

Product description

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

Code information (models, lots, serial numbers)

Kit UDI-DI: 04048551226087. Kit Serial Numbers: 2274269, 2273282, 2276217, 2276216, 2264656, 2275787, 2279756, 2280154, 2280379, 2275789, 2283453, 2277877, 2280204, 2273324, 2275986, 2283483, 2229591, 2273599, 2215800, 2274197, 2280156, 2275483, 2083136, 2275790, 2275482, 2274271, 2248338, 2283444, 2188673, 2276221, 2276217, 2275788, 2274199, 2283445, 2274198, 2274041, 2283716, 2274049, 2236228, 2279757, 2274267, 2275785, 2277894, 2230599, 2267785. 26153EAU/1 seals with expiration date: January 23, 2023.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

n.a. 11264BBU1
Karl Storz GmbH & Co. KG · HYSTEROSCOPE (AND ACCESSORIES)
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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