SynchroMed II Infusion Pump — Class II medical device recall Z-0137-2025
Ongoing recall by Medtronic Neuromodulation, reported 2024-10-30, distributed nationwide. Potential for error and inability to interrogate pump due to data corruption in the pump memory.
| Recall number | Z-0137-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2024-09-11 |
| Classified | 2024-10-21 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00643169630505 |
| Serial numbers | NGP004814H |
Product
SynchroMed II Infusion Pump. Product Number: 8637-20
Reason for recall
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
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-0137-2025. 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.