LASER Application Instrument — Class II medical device recall Z-1809-2024
Ongoing recall by Karl Storz Endoscopy, reported 2024-05-22, distributed nationwide. Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instr
| Recall number | Z-1809-2024 |
|---|---|
| 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 | 2024-04-01 |
| Classified | 2024-05-13 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR |
| Quantity | 85 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04048551164860, 04048551216392 |
| Lot numbers | 461000/04048551164860, 8694/04048551216392 |
| Model numbers | 461000, 8694 |
Product
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Reason for recall
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
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-1809-2024. 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.