Pentax Video Cystoscopes Recalled for Lack of FDA Clearance
Pentax of America Inc is recalling 24 Video Cystoscopes because they lack required FDA premarket notification clearance.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific physical injury or illness is reported in the source text.
Plain-English summary
Pentax of America Inc is recalling 24 units of Video Cystoscope models ECY-1570 and ECY-1570K. The recall was initiated because the devices lack 510(k) premarket notification clearance from the U.S. Food and Drug Administration.
The affected devices were distributed in eight states (CA, IL, MD, MI, ND, NH, NY, SD) and Guam. Specific serial numbers for the recalled units are listed in the agency's recall record.
Healthcare providers and consumers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Video Cystoscope models ECY-1570 and ECY-1570K
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopy
- Affected units
- 24
Distribution
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