FDAFDA recall Z-3333-2026 · Oct 7, 2026
Karl Storz Endoscopy: HOPKINS Telescope 30¿ recall
Recall found
Product
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.
Reason for recall
Due to incorrect inside packaging label for eyepiece.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z
- Quantity
- 6 eyepieces
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA and MO.
- Recalling firm
- Karl Storz Endoscopy, El Segundo, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-12
Source: openFDA enforcement record Z-3333-2026 · search recall number Z-3333-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.