Medivance Neonatal ArcticGel Pads — Class II medical device recall Z-1381-2024
Ongoing recall by Medivance Inc., reported 2024-04-03, distributed nationwide. Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling perfor
| Recall number | Z-1381-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medivance Inc., Louisville, CO, United States |
| Recall initiated | 2024-02-16 |
| Classified | 2024-03-26 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CN, JP, KR, SG, TH, TW |
| Quantity | 1,654 |
| UPC / GTIN / UDI-DI | 00801741132131, 00801741223457, 10801741132138 |
| Model numbers | 31802, 3180202, 31802C |
Product
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Reason for recall
Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
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-1381-2024. 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.