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Open, Classified

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.

FDA Recall Z-3333-2026 · Posted 2026-10-01

Recalling FirmKarl Storz Endoscopy
Recall StatusOpen, Classified
Product CodeEOB
Date Initiated2026-08-12
Product Quantity6 eyepieces

Reason for Recall

Due to incorrect inside packaging label for eyepiece.

Firm Action

On 08/12/2026, an "URGENT: MEDICAL DEVICE RECALL" Letter was sent via email informing customers that, KARL STORZ distributed 6 HOPKINS Telescope 30, 4mm REF: 10005BA between November 24, 2025, and December 15, 2025, that contains an optic (eyepiece) that is incorrectly etched with REF: 10005AA, which is a HOPKINS Telescope 0, 4 mm. The optic (eyepiece) inside the packaging is in fact a REF: 10005BA HOPKINS Telescope 30, 4mm, as the outer packaging indicates. Customers are instructed to: 1. Immediately check for impacted serial numbers in inventory and quarantine the incorrectly etched devices for return to Karl Storz. 2. Pass on this Urgent Medical Device Correction to all users of the products listed below (Table 1 and Table 2) and all other persons who need to be aware within your organization. 3. If customers have or may have distributed the products listed, identify and promptly notify those recipients with a copy of this notice and response form. 4. Return the completed Customer Reply Form by E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 5. Report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. For questions - email to [email protected].

Root Cause

Employee error

Distribution Pattern

U.S. Nationwide distribution in the states of AZ, CA and MO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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