Olympus MAJ-209 Suction Valves May Come Apart - Recall

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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy, PO Box 610 · Center Valley, PA 18034-0610

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling single-use suction valves for endoscopes because they might detach or get stuck inside the scope. This could cause injury during medical procedures if the valve fails to function properly.

Why it’s dangerous

The suction valves could detach or become stuck inside the endoscope during use. This might prevent proper fluid removal from the scope, potentially causing injury to the patient or the medical professional.

Who’s affected

Medical professionals using Olympus endoscopes with these specific suction valves are most at risk. Patients undergoing procedures with these valves may also be affected if the valve fails.

How to tell if you have this one

Check the model number on the valve packaging or label. The affected valves have lot numbers 88H, 89H, 8XH, 8YH, 8ZH, or 91H. These valves are used with Olympus endoscopes for procedures like bronchoscopy or cystoscopy.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Valve Lot Number
Look for the lot number on the valve packaging or label to determine if it's affected (88H, 89H, 8XH, 8YH, 8ZH, or 91H).

✎ GovInfoNow

Questions people ask

Why is this valve being recalled?

The valves may come apart or get stuck inside the endoscope during use, which could cause injury during medical procedures.

What should I do if I have this valve?

Check the lot number on the valve packaging or label. If it's one of the affected lot numbers (88H, 89H, 8XH, 8YH, 8ZH, or 91H), contact Olympus for guidance.

Are these valves safe to use?

The valves are not safe to use as they may detach or get stuck inside the endoscope, potentially causing injury.

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-2148-2019 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-2148-2019 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-2148-2019 (April 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2148-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Olympus Corporation of the Americas recalls Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be

Use caution until it’s fixed