FDA Device recall Z-3224-2024
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 by Karl Storz Endoscopy, citing various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3224-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-23 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | US |
Product
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Reason
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Identifiers
| code_info | All Lots/UDI: (01)04048551234099 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3224-2024%22
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