Olympus Biliary Stent Recall: Inadequate Package Seal Risks Infections

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Recalling firmAomori Olympus Co., Ltd.2 Chome 248-1, Okkonoki · Kuroishi, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling biliary stents model PBD-203-0703 due to a small percentage of sterile packages having inadequate seals. This could lead to infections if non-sterile equipment is used during medical procedures.

Why it’s dangerous

The stents come in sterile packages that sometimes have partial heat seals. If the seal is inadequate, the package may not be sterile, increasing the risk of infection during medical procedures.

Who’s affected

Healthcare professionals using these stents for endoscopic procedures may be affected. Patients undergoing biliary drainage procedures are at risk if non-sterile equipment is used.

How to tell if you have this one

Check for the model number PBD-203-0703 on the stent packaging. The product is used with endoscopes for endoscopic retrograde biliary drainage procedures.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Package Seal
Inspect the sterile package for adequate heat sealing; if the seal appears damaged, do not use the stent.

✎ GovInfoNow

Questions people ask

Is this recall affecting patients directly?

The recall affects healthcare professionals using the stents. Patients are at risk only if non-sterile equipment is used during procedures.

How common is this issue?

Inspection confirmed a small percentage of sterile packages have inadequate seals.

What should I do if I have this stent?

Check the package seal; if damaged, do not use the stent. Contact Olympus for further instructions.

Take action

Contact Olympus

We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1063-2021 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-1063-2021 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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Where this comes from

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.

Official source: FDA Recall #Z-1063-2021 (January 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1063-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Aomori Olympus Co., Ltd. recalls PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde

Lower-risk recall