Class 2 Device Recall UreteroRenoscope, 8 Fr., 6, 43cm

• Date Initiated by Firm: December 19, 2024
• Date Posted: January 30, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1058-2025
• Recall Event ID: 95975
• 510(K)Number: K233372
• Product Classification: Ureteroscope and accessories, flexible/rigid - Product Code FGB
• Product: KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6, 43cm, NON STERILE, RxONLY, CE 0123
• Code Information: All Lots/UDI: 04048551231371
• Recalling Firm/ Manufacturer: Karl Storz Endoscopy; 2151 E Grand Ave; El Segundo CA 90245-5017
• For Additional Information Contact: Ms. Kathy Strange; 424-218-8201
• Manufacturer Reason for Recall: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
• FDA Determined Cause: Labeling Change Control
• Action: 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.
• Quantity in Commerce: 5 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FGB