Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF:
FDA device recall Z-2794-2026 · posted 2026-07-23 · Open, Classified
Recall details
- Recalling firm
- Karl Storz Endoscopy
- 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.
- Action taken
- 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.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- HIH
- Quantity affected
- 45
- Distribution
- US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.
- Date initiated
- 2026-05-21
- Date posted
- 2026-07-23
- Location
- El Segundo, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE (K961605) | KARL STORZ Endoscopy-America, Inc. | 1996-11-13 |