Olympus Cystoscope Outer Sheath Recalled Due to Potential Device Tip Damage
Olympus Corporation of the Americas is recalling Olympus Cystoscope Outer Sheath (Model WA22810A) because it may be incompatible with GreenLight Laser therapy, potentially damaging the device tip.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where the hazard is a potential device malfunction/damage, but no injuries have been reported in the source text.
Plain-English summary
Olympus Corporation of the Americas is recalling Olympus Cystoscope Outer Sheath, Model/Catalog number WA22810A.
The product is being removed because it may be incompatible when used in conjunction with a GreenLight Laser for BPH therapy. This incompatibility could lead to damage to the tip of the device.
This recall affects 633 units distributed nationwide in the US. Users should be aware of this incompatibility when using the device with GreenLight Laser systems.
The recalled product
- Product
- Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 633
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model: WA2280A
- UDI: 04042761051729
- Lot#: All lots
Distribution
Distributed nationwide across the United States.
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