Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus… — Class II medical device recall Z-1548-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-09-18, distributed nationwide. Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off dur
| Recall number | Z-1548-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-03-01 |
| Classified | 2024-04-16 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,525 units |
| UPC / GTIN / UDI-DI | 04953170407857 |
| Model numbers | KD-645L |
Product
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L
Reason for recall
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
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-1548-2024. 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.