The FDA announced on August 12, 2026, that Karl Storz Endoscopy is recalling HOPKINS Telescope 30¿, 4mm REF 10005BA and HOPKINS¿ II telescopes due to incorrect inside packaging labels for the eyepiece. This Class II recall affects units distributed nationwide in Arizona, California, and Missouri.
How to tell if you have it
- Brand: Karl Storz
- Product: HOPKINS Telescope 30¿, 4mm REF 10005BA
- UDI-DI code: 04048551045121
- Product: KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes
- Material Number: 10005BA
- Serial Numbers: 100011, 100012, 10000Y, and 10000Z
The hazard
The recall is due to an incorrect inside packaging label for the eyepiece on the HOPKINS Telescope 30¿, 4mm REF 10005BA. The telescopes are intended for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures.
Context
GovInfoNow's records show Karl Storz Endoscopy has issued 24 other recalls since October 10, 2017. Recent brand recalls include a May 21, 2026 recall for Flexible Hystero-Fiberscope Kits regarding expired sterility seals and December 19, 2024 recalls for Pediatric Cysto-Urethroscopes and Optical Biopsy Forceps concerning unapproved reprocessing and sterility risks. Other recent recalls of similar products include a Covidien Shiley Tracheostomy Tube recall (April 15, 2026) and a Baxter Healthcare PRO+ 40" MRS SURFACE Mattress recall (August 18, 2026).