Flexible Hystero-Fiberscope Kits
Karl Storz recalls hysteroscope kits with expired endoscopic seals that may compromise sterility.
Check your inventory for Flexible Hystero-Fiberscope Kits with REF 11264BBU1 or 11264BBUK1. If the kit contains an expired Single Use Endoscopic Seal (REF 26153EAU/1), stop using it immediately and contact Karl Storz Endoscopy for return and replacement instructions.
Why it was recalled
Karl Storz Endoscopy is recalling Flexible Hystero-Fiberscope Kits (REF: 11264BBU1, 11264BBUK1) because they contain an expired Single Use Endoscopic Seal (REF: 26153EAU/1). The expired seal may compromise sterility assurance during diagnostic and operative hysteroscopic procedures.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Official source
Editorial summary by Recall Canary · last updated 2026-07-24 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification