3T Heater Cooler System — Class II medical device recall Z-0073-2024
Ongoing recall by LivaNova Deutschland GmbH, reported 2023-10-18, distributed nationwide. The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the
| Recall number | Z-0073-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova Deutschland GmbH, Munich, N/A, Germany |
| Recall initiated | 2023-08-03 |
| Classified | 2023-10-06 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 37 systems |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04033817900528 |
| Serial numbers | 20T31322, 20T31334, 20T31336, 20T31345, 20T31346, 20T31347, 20T31348, 20T31361, 20T31362, 20T31363, 20T31364, 20T31365, 20T31366, 20T31367, 20T31368, 20T31369, 20T31370, 20T31371, 20T31372, 20T31373, 20T31375, 20T31386, 20T31387, 20T31388, 20T31389 and 13 more |
| Model numbers | 16-02-85 |
Product
3T Heater Cooler System, REF: 16-02-85
Reason for recall
The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
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-0073-2024. 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.