FDA recall, , Moderate risk
Karl Storz Flexible Hystero-Fiberscope Kits
Flexible Hystero-Fiberscope Kits may contain an expired seal, impacting sterility assurance.
Summary by Recall Canary from the FDA notice
What happened
Karl Storz Endoscopy, based in El Segundo, California, recalled Flexible Hystero-Fiberscope Kits REF: 11264BBU1 and 11264BBUK1 because they may contain an expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1, which could impact the assurance of sterility. The kits are used in diagnostic and operative hysteroscopic procedures.
The company began the recall on May 21, 2026, and the FDA added it to its Enforcement Report on July 23, 2026. Distribution was nationwide in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, and VT.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
- UDI-DI
- 04048551226087
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Florida, Massachusetts, Minnesota, Texas, Ohio, New York, California, Michigan, Louisiana, Virginia, Maryland, Pennsylvania, Georgia, Wisconsin, Vermont.
- Company
- Karl Storz EndoscopyEl Segundo, California
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99027
- Recall number
- Z-2794-2026
All recalls from Karl Storz Endoscopy
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
