FDA Device recall Z-2193-2025
Sprinter Cart/Sprinter Cart XL Infusion Pole
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Sprinter Cart/Sprinter Cart XL Infusion Pole by Maquet Cardiopulmonary, citing device does not comply with the labeling requirements of international standard IEC 60601-1.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2193-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-27 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Maquet Cardiopulmonary |
| Distribution | US |
Product
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Reason
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Identifiers
| code_info | Model No. 701033599; UDI: 4037691257860. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2193-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.