Pentax recalls ED-3490TK duodenoscopes due to potential infection risk from outdated design. Replace with updated model per manufacturer instructions.
The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
Pentax is recalling ED-3490TK duodenoscopes because outdated parts could lead to infections during medical procedures. This affects hospitals and clinics using these instruments.
The duodenoscopes have outdated parts that could cause infections during medical procedures. The manufacturer says this risk is mitigated by updating the design and inspection procedures.
Hospitals and clinics that use Pentax ED-3490TK duodenoscopes are most at risk. Patients undergoing flexible endoscopy procedures may be affected if the instruments are not replaced.
Check for the model ED-3490TK on the instrument. The recall includes all units with the UDI design code 04961333232420.
Look for the model ED-3490TK on the instrument and the UDI design code 04961333232420.
The manufacturer says outdated parts could lead to infections during medical procedures, so they're updating the design and inspection procedures.
No, the recall is for replacement with updated models, not immediate stop-use.
Contact Pentax directly to arrange replacement with the updated design.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-0643-2018 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-0643-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
