Karl Storz Endoscopy: Hysteroscope (and Accessories)
Recall Summary Karl Storz Endoscopy is recalling Flexible Hystero-Fiberscope kits (model numbers 11264BBU1 and 11264BBUK1) because they contain expired sterile seals, which may compromise the sterility of the devices used in hysteroscopic procedures. These hysteroscopes are medical instruments used for diagnostic and surgical procedures inside the uterus. The affected products were distributed nationwide across multiple states.
- Recalling firm
- Karl Storz Endoscopy
- Product
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e0e02250-901a-4b19-a13c-28d6f6defee4