Olympus PBD-203-0710 Biliary Stent Recall: Risk of Infection from Poor Seal

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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 a specific biliary stent model because some packages may have poor seals, increasing infection risk. This is serious but affects only a small percentage of units.

Why it’s dangerous

The stent packaging may have inadequate seals, allowing non-sterile equipment to be used. This could lead to infections if the stent is not properly sterilized before medical use.

Who’s affected

Patients who received the PBD-203-0710 biliary stent during endoscopic procedures are likely affected. Healthcare providers using this model for drainage procedures are at risk.

How to tell if you have this one

Check for the model number PBD-203-0710 on the stent packaging. The product was 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 packaging for signs of inadequate sealing, such as gaps or improper heat application.

✎ GovInfoNow

Questions people ask

Is this stent dangerous if used properly?

The recall is for packaging issues, not the stent itself. Proper use with sterile equipment should be safe.

How common is this problem?

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

What should I do if I have this stent?

Check the packaging for seal issues and contact Olympus for guidance if concerns exist.

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-1066-2021 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-1066-2021 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-1066-2021 (January 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1066-2021 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-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde

Use caution until it’s fixed