Recirculator 8 — Class I medical device recall Z-2005-2021
Terminated recall by Eight Medical International BV, reported 2021-08-04, distributed nationwide. The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditio
| Recall number | Z-2005-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eight Medical International BV, Bergen Op Zoom, N/A, Netherlands |
| Recall initiated | 2021-06-04 |
| Classified | 2021-07-23 |
| Reported by FDA | 2021-08-04 |
| Terminated | 2023-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CO |
| Quantity | 22 |
| UPC / GTIN / UDI-DI | 08719992086016 |
| Lot numbers | 18687686, 19854184, 19854185, 19854186, 20018480, 20019438, 20021361, 20202106 |
Product
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.
Reason for recall
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
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-2005-2021. 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.