PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20 — Class II medical device recall Z-1010-2024
Ongoing recall by Angiodynamics, Inc., reported 2024-02-14, distributed in LA, MD, UT. Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion
| Recall number | Z-1010-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2023-12-18 |
| Classified | 2024-02-07 |
| Reported by FDA | 2024-02-14 |
| Distributed | LA, MD, UT |
| Countries outside the US | AT, CA, ES |
| Quantity | 7 eaches |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00787125004235, 15051684013109, 15051684013215, 15051684013291 |
| Lot numbers | 5793480, 5795344, 5795345 |
| Model numbers | 12500404, 12500415, 12500423 |
Product
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
Reason for recall
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
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-1010-2024. 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.