FDA Device recall Z-0363-2025
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC by Karl Storz Endoscopy, citing due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0363-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-21 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | US |
Product
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Reason
Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
Identifiers
| code_info | Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-07-29 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy - KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
FDA Device · Class II · 2025-02-05 · Karl Storz Endoscopy
All Karl Storz Endoscopy recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0363-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.