Olympus recalls PBD-203-0704 biliary stents with inadequate package seals that may cause infections. Affected units were sold in the U.S. from 2023. Consumers should check product labels and contact Olympus for details.
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 poor package seals, increasing infection risk during medical procedures. This is serious because infections can occur if the stent is not sterile.
The stent packaging may have a partial heat seal, allowing bacteria to enter. If the stent is not sterile, patients could get infections during medical procedures.
Patients who received the PBD-203-0704 biliary stent model from Olympus in the U.S. are at risk. Healthcare providers using the stent for endoscopic procedures may also be affected.
Check for the model number PBD-203-0704 on the stent packaging. The product was sold in the U.S. starting in 2023 for endoscopic biliary drainage procedures.
Look for the model number PBD-203-0704 on the stent packaging to confirm if it is affected.
Reach out to Olympus directly for further instructions on the recall.
The recall states that the packaging may have inadequate seals, but the stent itself is safe if properly sealed. However, the risk of infection exists if the seal is compromised.
Check for the model number PBD-203-0704 on the packaging. The product was sold in the U.S. starting in 2023 for endoscopic biliary drainage procedures.
The recall does not require immediate discontinuation; contact Olympus for specific instructions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1064-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1064-2021 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.
