FDA Device recall Z-1071-2025
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM…
- FDA Device
- Class I
- ongoing
- Published 2025-02-19
On 2025-02-19 the FDA classified a Class I recall of Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM… by Olympus, citing potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1071-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-01-15 |
| Published | 2025-02-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
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
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Identifiers
| code_info | 1. Model Number: K-201; UDI-DI: 04953170245466; All Lots. 2. Model Number: K-202; UDI-DI: 04953170245480; All Lots 3…1. Model Number: K-201; UDI-DI: 04953170245466; All Lots. 2. Model Number: K-202; UDI-DI: 04953170245480; All Lots 3. Model Number: K-203; UDI-DI: 04953170245503; All Lots 4. Model Number: K-204; UDI-DI: 04953170245527; All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1071-2025%22
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