CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report
Duodenoscope Product Usage: Intended to provide optical recalled
Pentax Medical is recalling Duodenoscope Product Usage: Intended to provide optical visualization, distributed nationwide in the US. The recall was initiated on 6 Apr 2016 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-2277-2016
- FDA event ID
- 73985
- Recalling firm
- Pentax Medical, Montvale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2016
- FDA classified
- 22 Jul 2016
- Reported
- 3 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 6 Apr 2016 | Recall initiated by company | |
| 22 Jul 2016 | Classified by FDA | +107 days |
| 3 Aug 2016 | 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
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Product as listed by the FDA
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Duodenoscope Product Usage: Intended to provide optical visualization recalled?
Yes. Pentax Medical recalled Duodenoscope Product Usage: Intended to provide optical visualization on 6 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-2277-2016.
Why was it recalled?
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Which lots are affected?
Model #'s FD-34V and ED-3490TK
Where was it sold?
US Nationwide Distribution
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 Medical
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Confocal GI Scope recalled by Pentax Medical | Pentax Medical | Other | Nationwide |
| Device | CLASS II | Gastroscope Product Usage: Intended to provide optical visualization recalled | Pentax Medical | Other | Nationwide |
| Device | CLASS II | Ultrasound Gastroscope recalled by Pentax Medical | Pentax Medical | Other | Nationwide |
| Device | CLASS II | Colonoscope Product Usage: Intended to provide optical visualization recalled | Pentax Medical | Other | Nationwide |
| Device | CLASS II | Signmoidoscope Product Usage: Intended to provide optical recalled | Pentax Medical | Other | Nationwide |
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| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
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| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
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