Olympus recalls B-V443Q-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 some 3-lumen extraction balloons used in endoscopy procedures because a small percentage have packaging seals that may not be properly sealed. This could lead to infections if the equipment is used without being sterile.
The sterile packaging may have partial heat seals, meaning the equipment could become non-sterile. If non-sterile equipment is used during endoscopy, patients might develop infections.
Healthcare professionals using the balloons during endoscopic procedures are most at risk. Patients receiving these procedures may be affected if the equipment is not properly sterile.
Check for model number B-V443Q-A on the packaging. The affected units were sold with version labels 06V, 07V, 08V, 09V, or 0XV.
Inspect the packaging for signs of inadequate sealing, though the recall does not specify how to identify this.
The recall states that a small percentage of units have packaging seals that may not be adequate, which could lead to infections if non-sterile equipment is used. The product is not safe for use without proper verification of sterility.
Look for the model number B-V443Q-A and version labels 06V, 07V, 08V, 09V, or 0XV on the packaging.
The recall does not specify a remedy, so contact Olympus directly for guidance on handling affected units.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0968-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0968-2021 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.
