# Class II recall Z-3333-2026: Karl Storz Endoscopy

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3333-2026 |
| Recalling firm | Karl Storz Endoscopy |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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 | Due to incorrect inside packaging label for eyepiece. |
| Quantity | 6 eyepieces |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA and MO. |
| Recall initiated | 2026-08-12 |
| Reported | 2026-10-07 |
| Firm location | El Segundo, CA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3333-2026%22). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.