DORO¿ Easy-Connect Navigation Adaptor — Class II medical device recall Z-1860-2025
Ongoing recall by Pro-Med Instruments Gmbh, reported 2025-06-04, distributed nationwide. Potential of compromised compatibility resulting in influence on the positioning of the reference array and an
| Recall number | Z-1860-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pro-Med Instruments Gmbh, Freiburg Im Breisgau, N/A, Germany |
| Recall initiated | 2025-03-14 |
| Classified | 2025-05-28 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CH, CN, CO, CY, CZ, DE, DZ, EC, EG, ES, FR, GB, HU, ID, IE, IL, IT, JP, LK, MX, NL, NO, PH, PL, QA, RU, SE, SG, SK, TH, TR, TW, UA, ZA |
| Quantity | 217 units |
| UPC / GTIN / UDI-DI | 04250435506738 |
| Serial numbers | 1102010, 1201002, 1201004, 1201005, 1201006, 1201008, 1201009, 1201011, 1206012, 1206013, 1206014, 1206015, 1206016, 1206018, 1310001, 1310002, 1310003, 1312001, 1312002, 1312003, 1312004, 1312005, 1312006, 1312007, 1312008 and 196 more |
| Model numbers | 1204.002 |
Product
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Reason for recall
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
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-1860-2025. 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.