Pentax recalls specific video colonoscope models (EC-2990Li to EC38-i10L) sold 2014-2021 due to updated reprocessing instructions. Owners should check model numbers and contact Pentax for details.
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Pentax is recalling certain video colonoscopes sold between 2014 and 2021. The recall is due to updated reprocessing instructions that may pose a risk if not followed correctly.
The devices require updated reprocessing instructions to prevent potential risks. If the reprocessing is not done correctly, there could be a risk of infection or equipment malfunction.
Medical professionals using Pentax video colonoscopes with specific model numbers. Patients who have undergone colonoscopy with these devices may be affected.
Check for model numbers EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L, or EC-3890TLK. These were sold in the US from April 2014 to May 2021.
Identify your colonoscope model from the list provided in the recall notice.
The recall is due to updated reprocessing instructions, not an immediate safety hazard. Proper reprocessing as per the updated instructions should ensure safety.
Check if your model number matches EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L, or EC-3890TLK.
Contact Pentax directly for guidance on the updated reprocessing instructions and any necessary actions.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-2448-2021 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-2448-2021 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.
