Pentax Video Bronchoscopes Recalled for Loose Suction Arms
Pentax of America Inc is recalling 1,701 video bronchoscopes due to loose suction arms. The 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 indicates a temporary or medically reversible adverse health consequence. The source text does not report any injuries, illnesses, or fatalities, and the defect is a mechanical issue (loose suction arms) rather than a high-risk pathogen or structural failure causing immediate severe harm.
Plain-English summary
Pentax of America Inc is recalling 1,349 units in the United States and 352 units internationally. The affected products are video bronchoscopes, specifically models EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK, and EB-1970UK.
The recall is due to loose suction arms on eleven models of endoscopes. This field action serves to retrospectively document the corrective actions taken by Pentax in 2010-2011 and to notify the FDA of these actions.
The products were distributed nationwide in the US and internationally. Healthcare providers should contact Pentax of America Inc for further instructions regarding the corrective actions taken.
The recalled product
- Product
- Video Bronchoscope
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscope
- 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 (7)
- Model #'s: EB-1170K
- EB-1570
- EB-1570AK
- EB-1570K
- EB-1970AK
- EB-1970K
- EB-1970TK and EB-1970UK
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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