CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
Sprinter Cart/Sprinter Cart XL Infusion Pole recalled
Maquet Cardiopulmonary is recalling Sprinter Cart/Sprinter Cart XL Infusion Pole, distributed nationwide in the US. The recall was initiated on 27 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2193-2025
- FDA event ID
- 97097
- Recalling firm
- Maquet Cardiopulmonary, Rastatt
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jun 2025
- FDA classified
- 29 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Jun 2025 | Recall initiated by company | |
| 29 Jul 2025 | Classified by FDA | +32 days |
| 6 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Where it was distributed
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, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Reunion, Romania, Russian Federation, Switzerland, Ukraine, United Kingdom, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Paraguay, Peru, Uruguay, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Pakistan, Qatar, Saudi Arabia, South Africa, United Arab Emirates, Yemen.
Questions about this recall
Why was it recalled?
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Which lots are affected?
Model No. 701033599; UDI: 4037691257860.
Where was it sold?
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, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Reunion, Romania, Russian Federation, Switzerland, Ukraine, United Kingdom, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Paraguay, Peru, Uruguay, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Pakistan, Qatar, Saudi Arabia, South Africa, United Arab Emirates, Yemen.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Maquet Cardiopulmonary
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|---|---|---|---|---|---|
| Device | CLASS II | Bubble Sensor for 3/8" x 3/32" tubing recalled by Maquet Cardiopulmonary | Maquet Cardiopulmonary | Device Malfunction | Nationwide |
| Device | CLASS II | Cardiohelp System HKH 8820 Wall Holder recalled | Maquet Cardiopulmonary | Device Malfunction | IL, MO |
| Device | CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary | Device Malfunction | PR, VA |
| Device | CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary | Device Malfunction | PR, VA |
| Device | CLASS II | Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag | Maquet Cardiopulmonary | Device Malfunction | PR, VA |
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