Karl Storz Endoscopy recalls HOPKINS Telescope 30¿

Due to incorrect inside packaging label for eyepiece.

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 KSEAProductLabeling@karlstorz.com.

• FDA enforcement recordOfficial FDA database entry for Z-3333-2026
• FDA 510(k) clearance · K945788The device's official FDA premarket clearance record
• FDA device classification · EOBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 874.4760The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Karl Storz EndoscopySearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.