Abbott Laboratories Inc. (St Jude Medical)

FDA Regulatory Profile

Abbott Laboratories Inc. (St Jude Medical) appears in FDA public data with 5 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1853-2021, Class II) was initiated on May 5, 2021.

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1853-2021Class IIv.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMateMay 5, 2021
Z-1855-2021Class IIWorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012May 5, 2021
Z-1854-2021Class IIv.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, TMay 5, 2021
Z-1549-2021Class IINeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000April 22, 2021
Z-1493-2019Class IITactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 April 5, 2019