Z-3333-2026 Class II Ongoing
FDA device recall Z-3333-2026 was initiated by Karl Storz Endoscopy on Aug 12, 2026 and is designated Class II. Reason for recall: Due to incorrect inside packaging label for eyepiece. The recall status is ongoing. Affected quantity: 6 eyepieces.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2026
- Initiation Date
- Aug 12, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 eyepieces
Product Description
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.
Distribution Pattern
U.S. Nationwide distribution in the states of AZ, CA and MO.
Code Information
Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3333-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026