CLASS II ONGOING Device recall · Reported 4 Mar 2026 · FDA Enforcement Report
Olympus Cystoscope Outer Sheath recalled by Olympus Corporation of the
Olympus Corporation of the Americas is recalling Olympus Cystoscope Outer Sheath, distributed nationwide in the US. The recall was initiated on 13 Sep 2024 and the FDA has classified it as Class II.
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-1437-2026
- FDA event ID
- 98300
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Sep 2024
- FDA classified
- 20 Feb 2026
- Reported
- 4 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Sep 2024 | Recall initiated by company | |
| 20 Feb 2026 | Classified by FDA | +525 days |
| 4 Mar 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
Product as listed by the FDA
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Where it was distributed
Distribution US nationwide.
Questions about this recall
Why was it recalled?
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
Which lots are affected?
Model: WA2280A; UDI: 04042761051729; Lot#: All lots;
Where was it sold?
Distribution US nationwide.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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