Lower risk Medical device recall · FDA · Published October 16, 2024

Maquet Acrobat-i Vacuum Stabilizer System Recall: Sterility Risk After 2 Years

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0486-2025Medical device Maquet ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmMaquet Cardiovascular, LLC45 Barbour Pond Dr · Wayne, NJ 07470-2094

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/53689-maquet-acrobat-i-vacuum-stabilizer-system-recall-sterility-risk-after.

Source Summary by GovInfoNow · govinfonow.com/recall/53689-maquet-acrobat-i-vacuum-stabilizer-system-recall-sterility-risk-after · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0486-2025

Cite this page

“Maquet Acrobat-i Vacuum Stabilizer System Recall: Sterility Risk After 2 Years.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/53689-maquet-acrobat-i-vacuum-stabilizer-system-recall-sterility-risk-after. Based on FDA recall #Z-0486-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0486-2025%22&limit=1).

The FDA announced on 2024-10-16 that Maquet Cardiovascular, LLC is recalling the Acrobat-i Vacuum Stabilizer System due to a compromised sterile barrier. The hazard poses an infection risk because sterility cannot be assured during the product's 2-year shelf life.

How to tell if you have it

Brand: Maquet
Product: Acrobat-i Vacuum Stabilizer System
Model Number: C-OM-10000Z
UDI-DI Number: 00607567100008
Units affected: 33,823

The hazard

Deviations in the manufacturing process created a compromise in the sterile barrier. Sterility cannot be assured during the duration of the product's 2-year shelf life.

Context

GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since 2019-01-24. Other recent recalls of similar products include Maquet Vasoview Hemopro 2: Gamma Sterilization Issue (2026-06-02), Maquet Heartstring III Proximal Seal System Recall: Risk of Hemostasis Failure (2025-08-15), and Maquet Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Recall: Out-of-Box Failures (2025-08-06). Other recent recalls of similar products include Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (2026-01-07), Medline Convenience Kits Recall: Calibration Issues May Impact Sterility (2026-01-07), and Zimmer Sterile Tourniquet Hoses Recall: Sterility Breach Risk (2026-06-09).

How to tell if you have this one

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.

Brand
Maquet
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-0484-2025	Acrobat-i Positioner. Model Number C-XP-5000Z; Model Number C-XP-5000Z. UDI-DI Number: 00607567500006. Batch Numbers: 3000272452, 3000289270, 3000293675, 3000340401, 3000382289, 3000282355, 3000287205, 3000290368, 3000306921, 3000308238, 3000307458, 3000318694, 3000282741, 3000290350, 3000306394, 3000334128, 3000355318, 3000362345, 3000278266, 3000343467, 3000353846, 3000346421, 3000360292, 3000364706, 3000317546, 3000272461, 3000343116, 3000360175, 3000360569, 3000355540, 3000380141, 3000378810, 3000334322, 3000363049, 3000311731, 3000306920, 3000365139, 3000273855, 3000300092, 3000276339, 3000347351, 3000347358, 3000352249, 3000397151, 3000368288, 3000293958, 3000288356, 3000286557, 3000402809, 3000392590, 3000340972.	14,338 units
Z-0485-2025	Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z; Model Number C-OM-9000Z. UDI-DI Number: 00607567900004. Batch Numbers: 3000270477, 3000274130, 3000279333, 3000325028, 3000349295, 3000356305, 3000368568, 3000288446, 3000314841, 3000318197, 3000340989, 3000315179, 3000284660, 3000279342, 3000325025, 3000340964, 3000274640, 3000280059, 3000280563, 3000325362, 3000284695, 3000314838, 3000349055, 3000356063, 3000298982, 3000317739, 3000376711, 3000279839, 3000399170, 3000362853, 3000337154, 3000321412, 3000299814, 3000288445, 3000269996.	10,778 units
Z-0486-2025	Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z; Model Number C-OM-10000Z. UDI-DI Number: 00607567100008. Batch Numbers: 3000277221, 3000286549, 3000315868, 3000317517, 3000322538, 3000339447, 3000363028, 3000270713, 3000275435, 3000275771, 3000280868, 3000284390, 3000303149, 3000321642, 3000342528, 3000336070, 3000322179, 3000337396, 3000273182, 3000282181, 3000337880, 3000353535, 3000364172, 3000357109, 3000276109, 3000338107, 3000354445, 3000355050, 3000352899, 3000324785, 3000360894, 3000370720, 3000323627, 3000346330, 3000356740, 3000278665, 3000344012, 3000366729, 3000361801, 3000400928, 3000363775, 3000311956, 3000343553, 3000367559, 3000377818, 3000341430, 3000367345, 3000336377, 3000316208, 3000381449, 3000380956, 3000403756, 3000321414, 3000361499, 3000407809, 3000398030, 3000387678, 3000320077, 3000277072, 3000283754, 3000296552, 3000320660, 3000339096, 3000347694, 3000348390, 3000352250, 3000279303, 3000277309, 3000282794, 3000283482, 3000350599, 3000351774, 3000351996, 3000365741, 3000369223, 3000369738, 3000393258, 3000323129, 3000273547, 3000366133, 3000391146, 3000273843, 3000280827, 3000295912, 3000346410, 3000401855, 3000384033, 3000382967, 3000378703, 3000363755, 3000316146, 3000295949, 3000398861, 3000394893, 3000380542, 3000361797, 3000350598, 3000320073, 3000299042, 3000295186, 3000288696, 3000284723, 3000274876, 3000363227, 3000285664.	33,823 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the model number C-OM-10000Z and batch numbers listed in the recall (e.g., 3000277221, 3000286549).

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 42 days after the firm started it.

Oct 16, 2024Firm started the recall
Nov 18, 2024FDA classified it Class II
Nov 27, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Maquet recalls

Link to this recall

<a href="https://govinfonow.com/recall/53689-maquet-acrobat-i-vacuum-stabilizer-system-recall-sterility-risk-after">Maquet Acrobat-i Vacuum Stabilizer System Recall: Sterility Risk After 2 Years (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0486-2025 (October 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0486-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.