Sprinter Cart/Sprinter Cart XL Infusion Pole — Class II medical device recall Z-2193-2025
Ongoing recall by Maquet Cardiopulmonary Gmbh, reported 2025-08-06, distributed nationwide. Device does not comply with the labeling requirements of international standard IEC 60601-1.
| Recall number | Z-2193-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiopulmonary Gmbh, Rastatt, Germany |
| Recall initiated | 2025-06-27 |
| Classified | 2025-07-29 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, CA, CH, CL, CO, CR, CY, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, LB, LT, LU, MX, NL, NO, NZ, OM, PE, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UA, UY, ZA |
| Quantity | 7,754 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04037691257860 |
| Model numbers | 701033599 |
Product
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Reason for recall
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2193-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.