The Recall Desk

Hazard

Control Failure recalls

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

What the numbers show

Total
14
Critical
0
Severe
0
Most recent
2026-06-24

Of the 14 control failure recalls 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 hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all control failure 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.

1–14 of 14

  • HighFDA (Devices)·Z-2412-2026·2026-06-24

    Philips Allura Xper hand switch buttons may not fully release

    Philips Allura Xper and MultiDiagnost Eleva systems are being recalled because the hand switch button may not fully release, potentially causing loss of imaging or unintended radiation exposure.

    Product
    Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2411-2026·2026-06-24

    Philips MultiDiagnost Eleva hand switch buttons may not fully release

    Philips MultiDiagnost Eleva systems are being recalled because the hand switch button may not fully release, potentially causing loss of imaging or unintended radiation exposure.

    Product
    Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 70803
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0501-2026·2025-11-19

    Positive control serum recalled over negative recovery of the HBsAg analyte

    Techno-Path is recalling 76 units of Multichem ID-B positive control serum because of potential negative recovery of the HBsAg analyte on the Alinity i platform.

    Product
    Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0502-2026·2025-11-19

    Second control serum lot recalled over negative HBsAg analyte recovery

    Techno-Path is recalling 51 units of Multichem ID-B positive control serum from a second lot because of potential negative recovery of the HBsAg analyte on the Alinity i platform.

    Product
    Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and ant
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2609-2025·2025-10-01

    FilmArray NGDS Warrior Panel diagnostic test system recall notice

    Biofire Defense is recalling the FilmArray NGDS Warrior Panel due to increased risk of internal control failures when testing positive blood cultures, which may delay results and require additional diagnostic evaluation.

    Product
    FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2025·2025-04-16

    FilmArra Pneumonia Panel Plus Diagnostic Kit Recalled for Control and Test Failures

    BioFire Diagnostics is recalling 29 units of the FilmArra Pneumonia Panel Plus test kit due to control failures and false negative results. Affected units (Lot 0979424) were distributed to France, Italy, Spain, Switzerland, and Israel.

    Product
    FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1240-2025·2025-03-05

    MRI System May Resume Scanning Above Safe Thermal Limits

    GE Healthcare's Brivo MR355 MRI system can incorrectly resume scans when tissue heating limits are exceeded, potentially causing thermal burns if patients contact conductive materials. The recall affects 22 systems distributed nationwide and internationally.

    Product
    Brivo MR355, NMRI system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2683-2024·2024-08-28

    FDA Recalls BioFire Pneumonia Diagnostic Test Kits for Control Failures

    BioFire Diagnostics recalls BIOFIRE FILMARRAY Pneumonia Panel plus test kits due to manufacturing defects that could lead to control failures and delayed test results. The affected kits were distributed in multiple US states and countries worldwide.

    Product
    BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2682-2024·2024-08-28

    BIOFIRE FILMARRAY Pneumonia Panel Recalled for Manufacturing Defect

    BioFire Diagnostics is recalling 58 units of BIOFIRE FILMARRAY Pneumonia Panel due to a manufacturing defect that increases the risk of control failures and delayed test results.

    Product
    BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2024·2023-11-22

    Medical Device Reagent Recalled for Unreliable Test Results

    Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.

    Product
    AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2618-2023·2023-09-27

    Omnipod 5 App Software Error Prevented Control on Android Phones

    Omnipod 5 app users on certain Android phones encountered an error that prevented remote control of the insulin delivery system. The issue delayed therapy access but did not interrupt automatic insulin delivery, and was resolved by Insulet restoring cloud security settings.

    Product
    Omnipod 5 Automated Insulin Delivery System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2056-2023·2023-07-12

    TrackMaster Treadmill Control Malfunction Can Cause Unexpected Acceleration

    Full Vision's TrackMaster treadmill can experience drive PCB malfunctions causing unexpected stopping, reversal, and acceleration. The malfunction affects 264 units distributed worldwide.

    Product
    TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2023·2023-01-11

    Nephrocheck Liquid Control Reagent Recall Due to Storage Condition Violation

    Biomerieux is recalling one batch of Nephrocheck Liquid Control Reagent because the product was stored outside proper temperature and time parameters, making performance unreliable.

    Product
    ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2021·2021-09-01

    Terumo Advanced Perfusion System Electronic Patient Gas System Recalled for Control Failure

    The Terumo Advanced Perfusion System 1 Electronic Patient Gas System is recalled for intermittent initialization failures that disable the primary control interface, requiring use of backup local controls.

    Product
    Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
    Category
    Medical Device
    Distribution
    0 states