Pentax Video Nasopharyngolaryngoscopes Recalled for Loose Suction Arms
Pentax of America Inc is recalling 1,701 Video Nasopharyngolaryngoscopes due to loose suction arms. The action documents corrective measures taken in 2010-2011.
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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard involves a structural defect (loose suction arms) on a medical device.
Plain-English summary
Pentax of America Inc is recalling 1,349 units of Video Nasopharyngolaryngoscopes in the United States and 352 units internationally. The affected devices are identified by Model Number VNL-1570STK. The recall covers eleven (11) models of endoscopes.
The recall is being issued to retrospectively document corrective actions taken by Pentax in 2010-2011 to address loose suction arms on the devices. The agency classification for this field action is Class II.
Consumers and healthcare facilities should contact Pentax of America Inc for further instructions regarding the corrective actions taken for these specific units.
The recalled product
- Product
- Video Naso pharyngo Laryngoscopes
- 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 #: VNL-1570STK
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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