CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report
Video Bronchoscope recalled by Pentax of America
Pentax of America is recalling Video Bronchoscope, distributed nationwide in the US. The recall was initiated on 11 Jan 2011 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2324-2017
- FDA event ID
- 77310
- Recalling firm
- Pentax of America, Montvale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2011
- FDA classified
- 9 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Jan 2011 | Recall initiated by company | |
| 9 Jun 2017 | Classified by FDA | +2341 days |
| 21 Jun 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
Product as listed by the FDA
Video Bronchoscope
Where it was distributed
US Nationwide and Internationally
Questions about this recall
Is Video Bronchoscope recalled?
Yes. Pentax of America recalled Video Bronchoscope on 11 Jan 2011. The recall is Class II and its status is Terminated. Recall number Z-2324-2017.
Why was it recalled?
This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
Which lots are affected?
Model #'s: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK and EB-1970UK
Where was it sold?
US Nationwide and Internationally
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pentax of America
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pentax Medical Video Processor recalled by Pentax of America | Pentax of America | Other | 20 states |
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