The Recall Desk

Hazard

Detection Failure recalls

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

What the numbers show

Total
15
Critical
0
Severe
2
Most recent
2025-09-03

Of the 15 detection 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 2 (13%) are Severe.

Which agencies issued them

About this hazard tag

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

1–15 of 15

  • ModerateFDA (Devices)·Z-2439-2025·2025-09-03

    Blood warmer units recalled because system may not detect inserted bag

    TherMax Blood Warmer Units, an accessory to the PrisMax system, are recalled because the system may be unable to detect a bag on the unit, causing setup difficulty or alarm T2284. 7,432 units are affected.

    Product
    TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1508-2025·2025-04-09

    Boppli Bedside Device Kit blood pressure monitor may fail to detect pressure changes

    Boppli bedside blood pressure monitors for infants may not adequately detect blood pressure changes due to vibratory noise. Affected monitors should be moved to patient's foot and ventilator lines kept away from the isolette.

    Product
    Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1164-2025·2025-02-19

    Diagnostic HPV Verification Panel Recalled Due to Quality Control Failures

    Microbiologics Inc is recalling HPV verification test panels (REF 8235) due to quality control failures that allowed defective units to be released. The panels may produce invalid test results or fail to detect HPV.

    Product
    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·25045·2024-11-14

    DeNova Detect Combination Alarms Recalled for Failure to Alert to Carbon Monoxide

    New Cosmos USA recalls about 26,360 DeNova Detect combination natural gas and carbon monoxide alarms because they can enter sleep mode and fail to alert consumers to dangerous gas levels. No injuries have been reported.

    Product
    DeNova Detect Brand Combination Natural Gas and Carbon Monoxide Alarms
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V554000·2024-07-24

    Tesla hood latches may not detect an unlatched hood after opening

    Tesla is recalling certain 2020-2024 Model 3, Model S, Model X and Model Y vehicles because the hood latch assembly may fail to detect an unlatched hood. 1,849,638 units affected.

    Product
    TESLA — TESLA MODEL S, MODEL 3, MODEL Y, MODEL X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1535-2024·2024-04-24

    Medical Device Airway Monitor Software Defect Prevents Obstruction Detection

    A software anomaly in SonarMed's AW-M0001 airway monitor prevents detection of partial airway obstructions in 2.5mm and larger sensors. The device may fail to alert clinicians to blockages, affecting approximately 145 units across 19 states.

    Product
    AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-1520-2024·2024-04-24

    SonarMed Airway Monitoring Sensor Fails to Detect Partial Obstruction

    SonarMed Inc is recalling 690 units of the AW-S030 NEO SONARMED SENSOR because the sensor fails to detect partial airway obstruction. The devices were distributed across 20 US states.

    Product
    AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1311-2023·2023-04-05

    Fluoroscopic X-Ray System Recalled for Unintended Table Movement Risk

    Siemens ARTIS pheno X-ray systems may experience unintended table movement that the system fails to detect, risking injury to patients, staff, or operators. The FDA is recalling 141 affected units nationwide.

    Product
    ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1646-2022·2022-09-07

    X-ray imaging system hardware defect may prevent operation

    Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.

    Product
    Artis pheno- Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2022·2022-08-24

    ARIES SARS-CoV-2 Assay may produce false negative diagnostic results

    Luminex Corporation recalled 257 units of the ARIES SARS-CoV-2 Assay (lot AB4042A) due to potential false negative results. The assay may fail to detect the ORF1ab gene, risking missed COVID-19 infections.

    Product
    ARIES SARS-CoV-2 Assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2925-2018·2018-09-05

    Stryker Mako Vizadisc Hip Procedure Tracking Kit Recall for Detection Failure

    Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Hip Procedure Tracking Kit because damaged reflective material may prevent camera detection.

    Product
    Stryker Mako Vizadisc Hip Procedure Tracking Kit
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1130-2018·2018-03-28

    Situate Gauze Recalled for Potential Failure to Detect by Console

    Covidien LLC is voluntarily recalling Situate Gauze RF and X-Ray detectable products due to a manufacturing error that may prevent detection by the Situate console.

    Product
    Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device t
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1885-2013·2013-08-14

    Siemens IMMULITE TSH Assay Recalled for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE Systems Third Generation TSH assays because a rare TSH variant is not detected.

    Product
    IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2013·2013-08-14

    Siemens Dimension TSH Flex Reagent Cartridge Recall for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling Dimension TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.

    Product
    Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide