FDA-Device2026-10-07Class IIMISBRANDING
Karl Storz HOPKINS Telescope 30° recalled for incorrect eyepiece packaging label
What this means
Karl Storz shipped HOPKINS Telescope 30° surgical visualization devices with an incorrect label on the eyepiece inside the packaging. The label error affects a small number of eyepieces (6 units) distributed in Arizona, California, and Missouri.
- Check your Karl Storz HOPKINS Telescope 30° (model REF 10005BA, serial numbers 100011, 100012, 10000Y, or 10000Z) for the incorrect eyepiece label.
- Contact Karl Storz Endoscopy for instructions on verification or replacement.
The agency's original wording
Hazard
Due to incorrect inside packaging label for eyepiece.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the states of AZ, CA and MO.
Affected count
6 eyepieces
Manufactured in
2151 E Grand Ave, El Segundo, CA, United States
Products
HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3333-2026More Karl Storz recalls
- FDA-Device2026-07-29Karl Storz Flexible Hystero-Fiberscope Kits recalled for expired sterile seals
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