Karl Storz HOPKINS Telescopes
Hopkins telescopes have an incorrect inside packaging label for the eyepiece.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Karl Storz Endoscopy is recalling the HOPKINS Telescope 30°, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS° and HOPKINS° II telescopes due to an incorrect inside packaging label for the eyepiece. The telescopes are used for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures. The recall began August 12, 2026, and was classified by the FDA on September 30, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
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.
- UDI-DI
- 04048551045121
Details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Arizona, California and Missouri.
- Event ID
- 99586
- Recall No.
- Z-3333-2026
- Company
- Karl Storz EndoscopyEl Segundo, California
- Hazard
- Labeling error
- Quantity recalled
- 6 eyepieces
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
