Class II — Abbott Laboratories Inc. (St Jude Medical)
| Recalling firm | ABBOTT LABORATORIES |
|---|---|
| Registered facility | View this company's 64 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. |
| Product | WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 |
| Quantity | 8 units |
| Distribution | US Nationwide distribution in the states of MI, KS, MO, TX. |
| Initiated | 2021-05-05 |
| Classified | 2021-06-14 |
| Terminated | 2024-06-18 |
| Recall number | Z-1855-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Abbott Laboratories Inc. (St Jude Medical) (Z-1855-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87904/
Alerts for ABBOTT LABORATORIES
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.