Olympus recalls PR-V614M 2-lumen cannulas with potential inadequate seals that could cause infections. Affected units sold in specific batches; stop using if unsure.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Olympus is recalling certain PR-V614M 2-lumen cannulas because some sterile packages have poor seals that could lead to infections. This affects patients using the cannulas for medical procedures.
The cannulas have a small percentage of sterile packages with partial heat seals. If the seal is inadequate, the equipment may not be sterile, increasing the risk of infections during medical procedures.
Patients using the recalled cannulas for medical procedures like biliary or pancreatic duct injections are most at risk. Healthcare providers who use these cannulas in endoscopies may also be affected.
Check for the model number PR-V614M on the cannula packaging. Affected units were sold in specific batch codes: 01K through 9ZK.
Inspect the seal on the cannula packaging for any signs of partial heat sealing.
The recall states that a small percentage of packages have inadequate seals, so it's not safe to use without checking the seal first.
Affected units include batch codes 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, and 9ZK.
Look for the model number PR-V614M on the packaging and check if it matches the affected batch codes listed in the recall.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0969-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0969-2021 from Olympus. 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.
