Maquet Sprinter Cart Infusion Pole Recall: Labeling Non-Compliance
Maquet recalls Sprinter Cart and XL Infusion Poles due to non-compliance with international labeling standards for medical devices. Affected units may not meet safety requirements.
Recall notice
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Contact the company
What happened, in plain English
Maquet is recalling Sprinter Cart and Sprinter Cart XL Infusion Poles because they do not meet international labeling standards. This could lead to safety issues with medical device use. Read more at govinfonow.com/recall/51955-maquet-sprinter-cart-infusion-pole-recall-labeling-non-compliance.
Source Summary by GovInfoNow · govinfonow.com/recall/51955-maquet-sprinter-cart-infusion-pole-recall-labeling-non-compliance · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2193-2025
Cite this page
“Maquet Sprinter Cart Infusion Pole Recall: Labeling Non-Compliance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51955-maquet-sprinter-cart-infusion-pole-recall-labeling-non-compliance. Based on FDA recall #Z-2193-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2193-2025%22&limit=1).
Why it’s dangerous
The device fails to meet international labeling standards required by IEC 606:1-1. This could mean critical safety information is missing, potentially affecting proper medical device use.
Who’s affected
Healthcare professionals using these infusion poles for medical treatments are most at risk. Patients receiving care through these poles may be affected if the labeling issue impacts device safety.
How to tell if you have this one
Check for model number 701033599 on the product. The UDI code 4037691257860 identifies affected units. These poles hold two 2 kg infusion bags for medical use.
- Brand
Maquet- Category
Medical device
What to do — step by step
Check Product Details
Look for model number 701033599 or UDI code 4037691257860 on the pole.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Hong Kong, India, Israel, Japan, Singapore, South Korea, Taiwan, Thailand, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,…” 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 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-2193-2025 (June 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2193-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.