Pentax recalls ED34-i10T2 duodenoscopes due to risk of distal end cap detaching during procedures, potentially causing mucosal injury or aspiration. Affected units may require immediate action.
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
Pentax is recalling all ED34-i10T2 duodenoscopes because the distal end cap can unexpectedly detach during use, which may cause patient injury or aspiration. This is a serious risk that requires immediate attention.
The distal end cap (OE-A63) can detach unexpectedly during procedures, potentially entering the patient's oral cavity. This may cause mucosal injury, lacerations, bleeding, or aspiration of the cap.
Medical professionals using Pentax ED34-i:10T2 duodenoscopes for endoscopic procedures are affected. Patients undergoing procedures with these devices face the highest risk of injury.
Check for the model number ED34-i10T2 on the duodenoscope. The recall applies to all units manufactured for medical use.
Immediately cease using the ED34-i10T2 duodenoscope if you have it, as detachment can cause serious injury.
No, this recall specifically applies to ED34-i10T2 models only.
If the end cap detaches, it may enter the patient's oral cavity, causing mucosal injury, lacerations, bleeding, or aspiration.
Check for the model number ED34-i10T2 on the device. All units of this model are affected.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-1682-2021 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-1682-2021 from Pentax. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
