Sapphire Infusion Pumps — Class I medical device recall Z-0094-2024
Ongoing recall by EITAN MEDICAL LTD, reported 2023-10-25, distributed nationwide. Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
| Recall number | Z-0094-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | EITAN MEDICAL LTD, Netanya, N/A, Israel |
| Recall initiated | 2023-09-11 |
| Classified | 2023-10-19 |
| Reported by FDA | 2023-10-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,383 |
| Reason classes | device malfunction, software |
| UPC / GTIN / UDI-DI | 07290109150109, 07290109150147, 07290109150161 |
| Model numbers | 15031-000-0028, 15032-000-0027, 15038-000-0001 |
Product
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Reason for recall
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
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-0094-2024. 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.