Flexible Hystero-Fiberscope Kits REF: 11264BBU1 recall (Karl Storz Endoscopy)
Medical deviceClass IIOngoing
Summary: Karl Storz Endoscopy is recalling 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.
What is being recalled
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT. (states named: California, Florida, Georgia, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, New York, Ohio, Pennsylvania, Texas, Virginia, Vermont, Wisconsin)
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2794-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 21, 2026 |
| Reported | July 29, 2026 |
| Company | Karl Storz Endoscopy |
| Company location | El Segundo, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 45 |
More recalls from Karl Storz Endoscopy · all medical device recalls · recalls from May 2026