The Recall Desk

Manufacturer

Abbott Laboratories Inc. (St Jude Medical)

5 recalls in our database name Abbott Laboratories Inc. (St Jude Medical) as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2021-06-23

Of the 5 recalls from Abbott Laboratories Inc. (St Jude Medical) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • HighFDA (Devices)·Z-1853-2021·2021-06-23

    WorkMate Claris Cardiac Monitoring System Software Error Causes Loss of Functionality

    Abbott's WorkMate Claris cardiac monitoring system may lose functionality or display a black screen during operation due to a software error affecting 4 distributed units.

    Product
    v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2021·2021-06-23

    Cardiac Monitoring System Software Error May Disable Device

    Abbott's WorkMate Claris cardiac monitoring system (Model H700124) is being recalled due to a software error that may disable the system or turn the screen black. Nine units affected in Michigan, Kansas, Missouri, and Texas.

    Product
    v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2021·2021-06-23

    WorkMate Claris v.1.2 Upgrade Kits Software Error Causes Function Loss

    WorkMate Claris v.1.2 Upgrade Kits may lose functionality or display a black screen during operation due to a software error.

    Product
    WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2021·2021-05-19

    Abbott NeuroTherm Radiofrequency Generator Recalled for Capacitor Failure

    Abbott is recalling 318 NeuroTherm NT2000iX Radiofrequency Generators due to potential capacitor failure that may cause output loss or smoky odors.

    Product
    NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1493-2019·2019-06-05

    Abbott TactiSys Quartz Equipment Recalled for Log Storage Defect

    Abbott is recalling 317 TactiSys Quartz Equipment units because a software defect prevents new log data from being stored, which may cause intermittent contact force data display.

    Product
    TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
    Category
    Medical Device
    Distribution
    0 states