The Recall Desk

Hazard

Data Accuracy recalls

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

What the numbers show

Total
7
Critical
0
Severe
1
Most recent
2025-07-09

Of the 7 data accuracy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (14%) 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 accuracy 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.

1–7 of 7

  • HighFDA (Devices)·Z-2079-2025·2025-07-09

    BD FACS 7-Color Setup Beads Recalled Due to Spectral Overlap Errors

    Becton, Dickinson and Company is recalling BD FACS 7-Color Setup Beads (REF 666289, Lots 85637 and 85638) because errors in the spectral overlap factors table may prevent accurate setup of flow cytometry instruments.

    Product
    REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-1776-2024·2024-05-15

    Stealth S8 neurosurgical navigation software display error affecting surgical guidance

    Medtronic's Stealth S8 surgical navigation software has a display bug that may omit digits, letters, or decimals from critical readings during brain surgery. FDA classified this as Class I due to serious potential surgical errors.

    Product
    Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2024·2024-01-03

    Liberty Select Cycler Displays Incorrect Timestamp on Treatment Reports

    Certain Liberty Select Cycler hemodialysis machines may display an incorrect timestamp on treatment data reports sent to clinics. No injuries or illnesses have been reported.

    Product
    Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1772-2019·2019-06-19

    Philips IntelliBridge System Recall for Infusion Pump Data Storage Accuracy Issues

    Philips is recalling IntelliBridge Systems configured with comma decimal separators because infusion pump data may be recorded at 100 times the actual values.

    Product
    Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later) Product Usage: The IntelliBridge System is indicated for use in data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2775-2016·2016-09-21

    Thermo Fisher Recalls Endura MD Mass Spectrometer Software Due to Data Accuracy Defect

    Thermo Fisher is recalling Endura MD Mass Spectrometer software versions 1.0 and 1.0 SP1 because a defect affects data accuracy.

    Product
    Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and qua
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1570-2016·2016-05-04

    BD Trucount Absolute Counting Tubes Recalled for Lot Mixing

    Becton, Dickinson and Company is recalling one lot of BD Trucount tubes because some pouches may contain tubes from a different lot, presenting a low risk to patient safety.

    Product
    BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flo
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2043-2015·2015-07-15

    Volcano Intravascular Ultrasound System Recalled for Interoperability Limitation

    Volcano Corp is recalling 227 intravascular ultrasound systems due to a limitation that may affect Fraction Flow Reserve calculations when connected to specific Philips monitors.

    Product
    Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular
    Category
    Medical Device
    Distribution
    Distributed nationwide