Maquet recalls Acrobat-i Vacuum Stabilizer System (model C-OM-10000Z) due to potential sterility compromise after 2 years. Affected units have specific batch numbers. Consumers should check their product for batch numbers and contact Maquet for details.
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Maquet is recalling its Acrobat-i Vacuum Stabilizer System (model C-OM-10000Z) because manufacturing flaws could compromise sterility during its 2-year shelf life. This means the device might not stay sterile after two years, which is critical for medical use.
The device's sterile barrier may become compromised during its 2-year shelf life due to manufacturing deviations. This means the device might not maintain sterility when used, which is critical for medical procedures where contamination could lead to infections.
Healthcare professionals using the Acrobat-i Vacuum Stabilizer System in medical settings are most at risk. Patients using this device for procedures could be affected if the sterility is compromised.
Check for model number C-OM-10000Z and batch numbers listed in the recall (e.g., 3000277221, 3000286549). The product was sold with specific batch numbers that are listed in the recall notice.
Look for the model number C-OM-10000Z and batch numbers listed in the recall (e.g., 3000277221, 3000286549).
The recall is due to manufacturing deviations that could compromise the sterile barrier, meaning the device might not stay sterile during its 2-year shelf life.
Check for model number C-OM-10000Z and batch numbers listed in the recall (e.g., 3000277221, 3000286549).
The recall does not specify a remedy, so contact Maquet directly for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0486-2025 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0486-2025 from Maquet. 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.
