BRAINLAB Curve — Class II medical device recall Z-2792-2020
Terminated recall by Brainlab AG, reported 2020-08-19, distributed in CA, RI, TX. Incorrect manufacturer calibration
| Recall number | Z-2792-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2020-07-16 |
| Classified | 2020-08-13 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2021-07-27 |
| Distributed | CA, RI, TX |
| Countries outside the US | AU, BG, BR, CA, DE, ES, FI, FR, HK, IL, IN, IT, JP, MA |
| Quantity | 18 units |
| UPC / GTIN / UDI-DI | 04056481138011 |
| Serial numbers | 0824912001-19900, 3911619001-19901, 5762713001-19905 |
Product
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Reason for recall
Incorrect manufacturer calibration
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-2792-2020. 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.