Single Use Guide Sheath Kit recallZ-1071-2025 · Olympus Corporation of the Americas · initiated Jan 15, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
FDA root cause category: Under Investigation by firm
What the company is doing
Olympus notified consignees on about 01/15/2024, via letter. Consignees were instructed to examine inventory and quarantine affected devices, cease usage of the product immediately, acknowledge receipt of the letter through the Olympus web portal, and to forward the notice to all applicable personnel and customers if further distributed.
Recall details
- Recall number
- Z-1071-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 15, 2025
- Posted by the FDA
- Feb 11, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 454 units
- Product code
- EOQ
- FDA submissions
- K060243
- Distribution
- US nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Single Use Guide Sheath Kit K-201Olympus Medical Systems Corp. · Bronchoscope (flexible or rigid)1 recall33 reports
- Single Use Guide Sheath Kit K-203Olympus Medical Systems Corp. · Bronchoscope (flexible or rigid)1 recall5 reports
- Single Use Guide Sheath Kit K-202Olympus Medical Systems Corp. · Bronchoscope (flexible or rigid)1 recall1 death4 reports
- Single Use Guide Sheath Kit K-204Olympus Medical Systems Corp. · Bronchoscope (flexible or rigid)1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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