Pentax Video Cytoscopes Recalled for Loose Suction Arms
Pentax of America Inc. is recalling Video Cytoscopes to correct loose suction arms. This action retrospectively documents corrections made in 2010-2011.
What this means for you
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. The source describes a retrospective documentation of corrective actions for a mechanical defect (loose suction arms) without reporting specific injuries or illnesses, fitting the criteria for a moderate risk or precautionary action.
Plain-English summary
Pentax of America Inc. is recalling Video Cytoscopes, specifically models ECY-1570 and ECY-1570K. The recall involves 1,349 units in the United States and 352 units internationally. The distribution pattern is US Nationwide and Internationally.
The recall is initiated to retrospectively document actions taken by Pentax to correct loose suction arms on eleven models of endoscopes. The source text indicates that these corrective actions were originally taken in 2010-2011 and are now being formally notified to the FDA.
Consumers and healthcare providers should verify if they possess these specific models. The recall serves to document the correction of the loose suction arms rather than reporting new incidents of injury or illness.
The recalled product
- Product
- Video Cytoscopes
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopes
- Hazard
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 (1)
- Model #'s:ECY-1570 and ECY-1570K
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Pentax of America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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