Olympus Single Use Guide Sheath Kits with the following product… — Class I medical device recall Z-1071-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2025-02-19, distributed nationwide. Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
| Recall number | Z-1071-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-01-15 |
| Classified | 2025-02-11 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 454 units |
| UPC / GTIN / UDI-DI | 04953170245466, 04953170245480, 04953170245503, 04953170245527 |
| Model numbers | K-201, K-202, K-203, K-204 |
Product
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202 3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203 4. Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-204. Used to collect cells or tissue specimens in the respiratory organs.
Reason for recall
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
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-1071-2025. 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.