The Recall Desk

Hazard

Data Error recalls

9 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9
Critical
0
Severe
3
Most recent
2026-08-05

Of the 9 data error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (33%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all data error recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–9 of 9

  • HighFDA (Devices)·Z-2821-2026·2026-08-05

    Bar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk

    Instrumentation Laboratory is recalling Bar Code Reader (BCR) wands used with GEM Premier 5000 and 7000 systems because they may assign patient results to the wrong patient ID.

    Product
    GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1379-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because the resulting impression or scanned data may cause incorrect rotation and margin contour misalignment.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1541-2018·2018-05-09

    PerkinElmer Specimen Gate Screening Center Software Recall for Data Errors

    PerkinElmer is recalling Specimen Gate Screening Center software due to potential errors in neonatal screening results, including false negatives and positives.

    Product
    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1761-2017·2017-04-19

    PerkinElmer Recalls Specimen Gate Laboratory Software Due to Data Errors

    PerkinElmer is recalling 29 units of Specimen Gate Laboratory software due to a potential for errors in patient results. The software is used for processing laboratory data.

    Product
    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1541-2017·2017-03-29

    Hitachi Echelon Oval MRI System Recalled for Image Data Errors

    Hitachi Medical Systems America Inc is recalling 25 Hitachi Echelon Oval MRI Systems because image data transferred to workstations showed errors on the slice position reference image.

    Product
    Hitachi Echelon Oval MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1542-2017·2017-03-29

    Hitachi Echelon MRI System Recalled for Image Data Transfer Errors

    Hitachi Medical Systems America Inc is recalling 68 Hitachi Echelon MRI Systems because image data transferred to workstations showed errors on the slice position reference image.

    Product
    Hitachi Echelon MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1144-2013·2013-04-24

    Vital Images Recalls Vitrea CT Cardiac Analysis Software Due to Data Errors

    Vital Images is correcting a defect in the Vitrea CT Multi-Chamber Cardiac Functional Analysis application where numerical values in the Results Table may be incorrect.

    Product
    Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea¿ CT…
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-0169-2013·2012-11-07

    Elekta MOSAIQ Medical Record System Recalled for Treatment Data Error

    Elekta, Inc. is recalling MOSAIQ electronic medical record systems because a user error led to a patient being seriously mistreated.

    Product
    MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view…
    Category
    Medical Device
    Distribution
    Distributed nationwide