Maquet recalls Acrobat SUV Vacuum Stabilizer System (model C-OM-9000Z) due to potential sterility compromise in its 2-year shelf life. Affected units have specific batch numbers.
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 SUV Vacuum Stabilizer System (model C-OM-9000Z) because manufacturing flaws may compromise the sterile barrier, risking contamination during the product's 2-year shelf life. This could lead to infections if used in medical settings.
The manufacturing process created a weakness in the sterile barrier that may allow contamination during the product's 2-year shelf life. This could lead to infections if the device is used in medical procedures without proper sterility.
Medical professionals using this device for patient care are most at risk. Patients receiving treatment with this device could be affected if the sterility barrier fails.
Check for model number C-OM-9000Z on the device. Affected units have specific batch numbers listed in the recall notice: 3000270477, 3000274130, and other batch numbers provided in the recall.
Look for the model number C-OM-9000Z on the device label.
Confirm if your device has one of the listed batch numbers: 3000270477, 3000274130, 3000279333, and others.
The recall states that the device may have a compromised sterile barrier, so it should not be used until the recall is addressed.
Check for model number C-OM-9000Z and one of the specific batch numbers listed in the recall notice.
The recall does not specify a remedy, so contact Maquet directly for guidance on next steps.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0485-2025 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0485-2025 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.
