FDA Medical devices recall ·
KARL STORZ - ENDOSKOPE recall
- Recall number
- Z-1055-2025
- Date
- (initiated December 19, 2024)
- Company / brand
- Karl Storz Endoscopy
2151 E Grand Ave, El Segundo, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1510 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Why was it recalled?
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots/UDI: 04048551231333
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1055-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.