Olympus recalls B-V243Q-A 3-Lumen extraction balloons due to potential inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected units sold in specific versions.
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 certain 3-lumen extraction balloons that may have inadequate sterile packaging seals. This could lead to infections if non-sterile equipment is used during medical procedures.
The sterile packaging may have partial heat seals, meaning the equipment could become non-sterile. If non-sterile equipment is used during endoscopic procedures, patients may develop infections.
Healthcare professionals using these balloons during endoscopic procedures are most at risk. Patients using the balloons for stone removal may face infection if non-sterile equipment is used.
Check for model number B-V243Q-A on the packaging. Affected units were sold in versions 03V through 0XV.
Inspect the packaging for partial heat seals that may indicate inadequate sterility.
The recall indicates a small percentage of units may have inadequate sterile packaging seals, so it's not safe to use without checking the seal.
Look for model number B-V243Q-A on the packaging. Affected units were sold in versions 03V through 0XV.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0967-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0967-2021 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.
