Olympus recalls PBD-203-0707 biliary stents with potential inadequate package seals, risking infections. Affected units sold in 95K-99K batches. Contact for remedy.
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 biliary stents that may have inadequate package seals, which could lead to infections if used. This affects patients who received these stents during endoscopic procedures.
The stents may have partial heat seals on their sterile packaging. If the seal is inadequate, the equipment could become non-sterile, increasing the risk of infection during medical procedures.
Patients who received the PBD-203-0707 biliary stents during endoscopic procedures between 95K and 99K batches are most at risk. Healthcare providers using these stents for biliary drainage are also affected.
Check for the model number PBD-203-0707 on the stent packaging. The product was sold in batches labeled 95K through 99K.
Reach out to Olympus directly for instructions on how to handle the recalled stents.
The recall involves a small percentage of stents with potential inadequate package seals that could lead to infections if non-sterile equipment is used. However, the risk is low as only a small percentage of packages are affected.
Check for the model number PBD-203-0707 on the packaging and look for batch numbers between 95K and 99K.
Contact Olympus directly for instructions on how to handle the recalled stents.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1065-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1065-2021 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.
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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.
