Karl Storz Endoscopy recalls KARL STORZ - ENDOSKOPE

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

On December 19, 2024, Karl Storz, issued an "Urgent: Medical Device Correction" notification to affected consignees via UPS. In addition to informing consignees about the recall, Karl Storz asked consignees to take the following actions: 1. Immediately discard any previous revisions of the IFU. 2. Access the updated e-IFU at the following link: https://www.karlstorz.com/de/en/eifu.htm?q=&country=US 3. Pass on this Urgent Medical Device Correction to all users of the recalled products and all other persons who need to be aware within your organization. 4. If you have or may have distributed the products listed, please identify and promptly notify those recipients with a copy of this notice, response form and updated e-IFU. 5. Return the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 6. Please 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. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• FDA enforcement recordOfficial FDA database entry for Z-1063-2025
• FDA 510(k) clearance · K233372The device's official FDA premarket clearance record
• FDA device classification · FGBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1500The 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.