FDA Medical Device Recalls (openFDA)
Karl Storz Endoscopy: Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
- Recall number
- Z-2794-2026
- Recalling firm
- Karl Storz Endoscopy
- Product
- Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
- Status
- Open, Classified
- Initiated
- 2026-05-21
- Posted
- 2026-07-23
- Terminated
- not on file
- 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.
- Root cause
- Packaging change control
- 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 KSEAProductLabeling@karlstorz.com For all other questions regarding this communication, please send an email to KSEAProductLabeling@karlstorz.com.
- Quantity
- 45
- Distribution
- US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- K961605
- PMA numbers
- not on file
- Product code
- HIH
- Firm FEI
- 3007475226
- Firm city
- El Segundo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28