Olympus recalls B-V233P-A extraction balloons due to potential inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected units include specific model versions sold in certain regions.
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 the balloons are used without proper sterility.
The sterile packaging may have partial heat seals, meaning the balloons could become non-sterile. If non-sterile equipment is used during endoscopic procedures, patients may develop infections.
Medical professionals using the balloons for endoscopic procedures, particularly those in regions where the specific model versions were sold. Patients at risk are those who received the recalled balloons during procedures.
Check for model number B-V233P-A on the packaging. Affected units include versions labeled 02V through 09V and 0XV. These were sold in specific regions.
Inspect the packaging for signs of partial heat sealing, which may indicate inadequate sterility.
Yes, model numbers B-V233P-A with versions 02V through 09V and 0XV are affected.
Patients may develop infections if non-sterile equipment is used during endoscopic procedures.
The recall does not specify a remedy; users should check the packaging seal and avoid using if the seal appears compromised.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0966-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0966-2021 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.
