The Recall Desk

Hazard

Performance Degradation recalls

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

What the numbers show

Total
43
Critical
0
Severe
0
Most recent
2026-07-08

Of the 43 performance degradation 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 performance degradation 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.

26–43 of 43

  • ModerateFDA (Devices)·Z-0867-2023·2023-01-11

    Biomerieux VIDAS Estradiol II Test Systems Recalled for Storage Condition Exceedance

    Biomerieux Inc is recalling VIDAS Estradiol II 60 Tests (Catalog 30431-01, Batch 1009378680) distributed nationwide after temperature and time storage conditions were exceeded, potentially compromising test reliability.

    Product
    VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0836-2023·2023-01-11

    FDA Recalls VITEK 2 AST-GN79 Reagent Test Kit for Temperature Excursion

    Biomerieux Inc. is recalling 310 units of the VITEK 2 REAGENT AST-GN79 TEST KIT (batches 5992201403 and 5992253503) nationwide because temperature and time conditions exceeded specified ranges, preventing guaranteed product performance.

    Product
    VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0803-2023·2023-01-11

    PPM Clinical Chromid VRE Culture Media Recalled for Storage Excursion

    Biomerieux is recalling PPM Clinical Craponne Chromid VRE culture media because storage conditions (temperature and time) exceeded specifications. Batch 1009540400 was distributed nationwide in the United States.

    Product
    PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2023·2023-01-11

    PPM Lombard R2A Laboratory Medium Recalled for Exceeded Storage Conditions

    Biomerieux Inc is recalling PPM Lombard R2A medium products (lot 1009527290) because storage conditions exceeded acceptable parameters, compromising product performance. Approximately 20 units distributed nationwide in the United States.

    Product
    PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0825-2023·2023-01-11

    ETEST Clinical Imipenem Susceptibility Test Kits Recalled Due to Storage Deviation

    Biomerieux Inc. is recalling ETEST Clinical Imipenem IP 32 susceptibility test kits nationwide because temperature and time storage conditions were exceeded, which may affect product performance.

    Product
    ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0790-2023·2023-01-11

    VITEK 2 BCL Test Kit recalled for storage condition violations

    A batch of VITEK 2 Reagent BCL Test Kit from Biomerieux Inc is being recalled because storage conditions were exceeded, and product performance cannot be guaranteed.

    Product
    VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0820-2023·2023-01-11

    FDA Recalls ETEST Clinical Benzylpenicil Test Due to Storage Excursion

    Biomerieux Inc recalls ETEST Clinical Benzylpenicil susceptibility test kits due to temperature and time excursions during storage that affect product performance. Batch 1009477980 was distributed nationwide.

    Product
    ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1214-2022·2022-06-08

    BD Anti-Kappa Flow Cytometry Reagents Recalled for Uncharacteristic Flow Profiles

    BD Anti-Kappa APC and PE reagents used in flow cytometry testing may exhibit uncharacteristic flow profiles, potentially affecting test accuracy. Worldwide distribution to 249 units across US states and Taiwan.

    Product
    BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cyto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2033-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Ingress

    Advanced Bionics is recalling HiResolution Bionic Ear Systems because body fluid can enter the device, causing hearing performance degradation.

    Product
    AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Entry

    Advanced Bionics is recalling 8,159 HiResolution Bionic Ear Systems because body fluid may enter the device, causing hearing performance degradation.

    Product
    AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2918-2018·2018-08-29

    Euro Diagnostica Immunoscan CCPlus Test Kits Recalled for Decreasing Performance

    Euro Diagnostica AB is recalling 25 Immunoscan CCPlus test kits due to decreasing performance over time. The kits were distributed in Minnesota, Texas, and Iran.

    Product
    Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2252-2016·2016-07-27

    BD Trucount Tubes Recalled for Potential Sealing Defects

    Becton, Dickinson and Company is recalling one lot of BD Trucount Absolute Counting Tubes because they may not be sealed properly, which can degrade product performance.

    Product
    BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1607-2016·2016-05-11

    Toshiba Celesteion PET/CT Systems Recalled for Detector Performance Degradation

    Toshiba American Medical Systems is recalling three Celesteion PET/CT systems due to potential degradation of detector performance.

    Product
    Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0749-2016·2016-02-10

    bioMérieux Recalls BacT/ALERT SN Culture Bottles Due to Shipping Exposure

    bioMérieux is recalling 2,741 BacT/ALERT SN culture bottles because non-normal shipping conditions may have degraded the media, potentially impacting microbial growth performance.

    Product
    BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0029-2014·2013-10-30

    OPTI LION E-Plus Cassettes Recalled for Incorrect Barcode Labeling

    OPTI Medical Systems is recalling OPTI LION E-Plus Cassettes because incorrect barcodes may affect performance over time and cause quality control failures.

    Product
    Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2013·2012-12-12

    Siemens syngo.plaza Radiological Image Processing System Software Update Recall

    Siemens Medical Solutions USA, Inc. is recalling 15 syngo.plaza systems to address unintended software behavior that may affect system performance.

    Product
    Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2013·2012-11-28

    SenTec V-Sign Membrane Changer Recalled for Manufacturing Defect

    Sentec AG is recalling 195 boxes of SenTec V-Sign Membrane Changers due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 performance.

    Product
    SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxy
    Category
    Medical Device
    Distribution
    1 state