Data Foundry

Medical device recalls 2025

AW Server 2 — Class II medical device recall Z-0068-2026

Ongoing recall by GE Medical Systems, SCS, reported 2025-10-15, distributed nationwide. Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could comp

Recall numberZ-0068-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGE Medical Systems, SCS, Buc, France
Recall initiated2025-09-05
Classified2025-10-08
Reported by FDA2025-10-15
DistributedNationwide (US)
UPC / GTIN / UDI-DI00082421040292, 00082421040407, 00082421040629, 00082421060214, 00082421070664, 00082421090648, 00082421090747, 00082421091065, 00082421100767, 00082421100835, 00082421120437, 00082421130160, 00082421140862, 00082421150328, 00082421160334, 00082421160679, 00082421160716, 00082421170111, 00082421190317, 00082421200344, 00082421200528, 00082421210732, 00082421240302, 00082421280100, 00082421310487 and 8 more

Product

AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

Reason for recall

Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.

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-0068-2026. 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.