FDA Device recall Z-2589-2023
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class II recall of Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only by Karl Storz Endoscopy, citing flexible intubation endoscopes sterility assurance can not be confirmed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2589-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-07 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | US |
Product
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Reason
Flexible intubation endoscopes sterility assurance can not be confirmed.
Identifiers
| code_info | UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 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-2589-2023%22
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