WorkMate Claris v — Class II medical device recall Z-1855-2021
Terminated recall by Abbott Laboratories Inc. (St Jude Medical), reported 2021-06-23, distributed nationwide. Due to a software error, the user may lose functionality of the system or the screen may turn black during ope
| Recall number | Z-1855-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories Inc. (St Jude Medical), Saint Paul, MN, United States |
| Recall initiated | 2021-05-05 |
| Classified | 2021-06-14 |
| Reported by FDA | 2021-06-23 |
| Terminated | 2024-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 8 units |
| Reason classes | software |
| Model numbers | H800007, H800012 |
Product
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Reason for recall
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
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-1855-2021. 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.