Five S 5 3x65 — Class II medical device recall Z-2589-2023
Ongoing recall by Karl Storz Endoscopy, reported 2023-09-27, distributed nationwide. Flexible intubation endoscopes sterility assurance can not be confirmed.
| Recall number | Z-2589-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy, El Segundo, CA, United States |
| Recall initiated | 2023-07-07 |
| Classified | 2023-09-15 |
| Reported by FDA | 2023-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 218 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04048551446690 |
| Model numbers | 0915612-06 |
Product
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Reason for recall
Flexible intubation endoscopes sterility assurance can not be confirmed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2589-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.