3 — Class II medical device recall Z-1678-2025
Ongoing recall by Belmont Instrument LLC, reported 2025-05-07, distributed nationwide. Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a f
| Recall number | Z-1678-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Belmont Instrument LLC, Billerica, MA, United States |
| Recall initiated | 2025-03-31 |
| Classified | 2025-04-25 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, IT, NO |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00896128002534 |
| Lot numbers | 20240911, 20241004, 20241011, 20241105 |
| Model numbers | 903-00032 |
Product
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the same case for shipment. The female quick connector that may be cracked is located on the Heat Exchanger/Patient Line set.
Reason for recall
Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
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-1678-2025. 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.