FlexLab Automation Modules — Class II medical device recall Z-0591-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-11-23, distributed nationwide.
| Recall number | Z-0591-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2016-09-29 |
| Classified | 2016-11-16 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2018-09-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BD, BE, BH, BR, CA, CH, CN, CZ, DE, DK, EG, ES, GB, GR, ID, IT, KR, LB, MY, PH, PT, QA, SA, SE, TR, TW, VN |
| Quantity | 448 units |
Product
FlexLab Automation Modules
Reason for recall
Not stated by FDA.
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-0591-2017. 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.