CLASS I ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report
Olympus Single Use Guide Sheath Kits recalled
Olympus Corporation of the Americas is recalling Olympus Single Use Guide Sheath Kits with the following product descriptions, distributed nationwide in the US. The recall was initiated on 15 Jan 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1071-2025
- FDA event ID
- 96087
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 15 Jan 2025
- FDA classified
- 11 Feb 2025
- Reported
- 19 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 15 Jan 2025 | Recall initiated by company | |
| 11 Feb 2025 | Classified by FDA | +27 days |
| 19 Feb 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Product as listed by the FDA
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.
Where it was distributed
US nationwide distribution.
Questions about this recall
Why was it recalled?
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Which lots are affected?
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
Where was it sold?
US nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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