FDA-Device2026-07-29Class IIPACKAGING DEFECT
Karl Storz Flexible Hystero-Fiberscope Kits recalled for expired sterile seals
What this means
Karl Storz Flexible Hystero-Fiberscope Kits with certain serial numbers contain expired single-use endoscopic seals that may not maintain sterility during gynecological procedures. The affected seals expired in January 2023 and were distributed across 15 U.S. states.
- Check if your kit's serial number matches the affected list (45 kits total).
- Do not use affected kits in clinical procedures.
- Contact Karl Storz or your distributor for instructions on replacement or return.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.
Affected count
45
Manufactured in
2151 E Grand Ave, N/A, El Segundo, CA, United States
Products
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2794-2026Want us to check the next one for you?
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