CLASS II Device recall · Reported 2 Jun 2021 · FDA Enforcement Report
Pentax Medical Video Duodenoscope recalled by Pentax of America
Pentax of America is recalling Pentax Medical Video Duodenoscope, distributed nationwide in the US. The recall was initiated on 21 Apr 2021 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-1682-2021
- FDA event ID
- 87763
- Recalling firm
- Pentax of America, Montvale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Apr 2021
- FDA classified
- 25 May 2021
- Reported
- 2 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 21 Apr 2021 | Recall initiated by company | |
| 25 May 2021 | Classified by FDA | +34 days |
| 2 Jun 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration
Product as listed by the FDA
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
Where it was distributed
US Nationwide distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C.
Nationwide AlabamaCaliforniaDistrict of ColumbiaLouisianaMarylandMichiganMissouriNorth CarolinaNew JerseyPennsylvaniaTexas
Questions about this recall
Why was it recalled?
IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration
Which lots are affected?
All units
Where was it sold?
US Nationwide distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C.
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 26 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 |
| Device | CLASS II | Pentax Medical Video Colonoscope- Intended to provide recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Pentax Medical Video Upper GI Scope-Intended to provide recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Pentax Medical Video Processor- Intended to be used recalled | Pentax of America | Other | Nationwide |
| Device | CLASS II | Colonoscope Family # 1-Pentax Video Colonoscopes recalled | Pentax of America | Other | Nationwide |
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