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.

1–25 of 43

  • ModerateFDA (Devices)·Z-2669-2026·2026-07-08

    Solar GI System Water Perfusion Units Recalled Due to Moisture Accumulation

    Laborie Medical Technologies is recalling Solar GI System (Water Perfusion) units worldwide because moisture may accumulate in internal tubing and filters under extended use, potentially affecting airflow and pressure measurement performance.

    Product
    Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0840-2023·2023-01-11

    Gene-Up Lysis Kit Recalled Due to Storage Condition Violations

    Biomerieux Inc is recalling Gene-Up Lysis Kit (Catalog 414057) because storage conditions were exceeded and product performance cannot be guaranteed. Nationwide distribution.

    Product
    GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0795-2023·2023-01-11

    VIDAS Varicel Zoster IGG 60T Recalled Due to Storage Condition Excursion

    Biomerieux Inc is recalling VIDAS Varicel Zoster IGG 60T (Catalog 30217, Batch 229478) due to storage temperature and time exceedance. The recalled units cannot be guaranteed to perform accurately.

    Product
    VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2023·2023-01-11

    TEMPO Control Kit Reagents Recalled Due to Storage Temperature Excursion

    Biomerieux is recalling TEMPO REAGENTS TEMPO CONTROL KIT (catalog 80000) due to storage conditions exceeding temperature and time limits, compromising product performance. Batch 1009477900 was distributed nationwide.

    Product
    TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2023·2023-01-11

    Medical Device Test Kit Recalled Due to Storage Condition Exceedance

    Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT nationwide due to storage conditions exceeding acceptable ranges, which cannot guarantee product performance.

    Product
    VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2023·2023-01-11

    Clinical Diagnostic Device Recall: ETEST Rifampicin RI 32 Performance Degradation

    Biomerieux Inc is recalling ETEST CLINICAL RIFAMPICIN RI 32 clinical diagnostic strips because temperature and time storage parameters were exceeded, and product performance cannot be guaranteed.

    Product
    ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0838-2023·2023-01-11

    Medical device test kit recalled due to storage temperature and time excursion

    Biomerieux Inc is recalling the VITEK 2 REAGENT AST-GN81 Test Kit after storage conditions exceeded specified ranges, preventing guaranteed product performance. The recall affects 34 units distributed nationwide.

    Product
    VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2023·2023-01-11

    ETEST Clinical Erythromycin test plates recalled for storage temperature deviation

    Biomerieux Inc is recalling ETEST Clinical Erythromycin EM 256 US S30 test plates (batch 1009157090) distributed nationwide. Product performance cannot be guaranteed due to temperature and time storage conditions that exceeded specifications.

    Product
    ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
    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-0848-2023·2023-01-11

    VITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance

    Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.

    Product
    VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2023·2023-01-11

    PPM Lombard TSA Neutralizer Culture Media Recalled for Storage Defect

    Biomerieux is recalling 74 units of PPM Lombard Products TSA 3P neutralizer culture media due to temperature and time storage excursions. Product performance cannot be guaranteed.

    Product
    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2023·2023-01-11

    API JAMES 2AMP Clinical Diagnostic Device Recall Due to Storage Condition Violations

    Biomerieux Inc is recalling API JAMES 2AMP clinical diagnostic devices due to improper temperature and time storage conditions that may affect product performance. Affected units nationwide should not be used.

    Product
    API JAMES 2AMP, CATALOG 70542
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2023·2023-01-11

    PPM Lombard Phosphate Buffer Recall Due to Temperature Exposure

    Biomerieux Inc is recalling PPM Lombard Phosphate Buffer products due to temperature and time exposure during storage or transport that may have compromised product performance.

    Product
    PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2023·2023-01-11

    FDA Recalls VITEK 2 Reagent GP Test Kit Due to Temperature Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT GP TEST KIT units nationwide due to temperature and time parameters exceeding acceptable ranges, which may affect test performance.

    Product
    VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2023·2023-01-11

    FDA Recalls Reagent Nozzle Cleaning Solution Due to Storage Temperature Exceedance

    Biomerieux Inc is recalling a reagent nozzle cleaning solution (Catalog 29588) because storage temperature and time conditions were exceeded, preventing product performance guarantee.

    Product
    PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2023·2023-01-11

    ETEST Clinical Vancomycin Test Kits Recalled Due to Storage Damage

    Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 test kits due to storage temperature excursions that may compromise test performance. Affected kits were distributed nationwide.

    Product
    ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2023·2023-01-11

    Biomerieux VIDAS RUB IGG Tests Recalled Due to Storage Conditions

    Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.

    Product
    VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2023·2023-01-11

    Biomerieux API 20 E 25 Strips Recalled for Storage Condition Failure

    Biomerieux Inc is recalling API 20 E 25 Strips (Batch 1009226560) because temperature and time excursions during storage exceeded specified parameters. Product performance cannot be guaranteed.

    Product
    API 20 E 25 STRIPS, CATALOG 20100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2023·2023-01-11

    Listeria Detection Test Strips Recalled for Unreliable Performance

    Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.

    Product
    API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2023·2023-01-11

    Measles Antibody Test Kits Recalled Due to Temperature Excursion

    Biomerieux Inc recalled VIDAS Measles IgG diagnostic test kits due to temperature and time excursions during storage or transport. Affected batch 1009421810 distributed nationwide; product performance cannot be guaranteed.

    Product
    VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0855-2023·2023-01-11

    Medical Device Reagent Recalled for Temperature Storage Condition Failure

    Biomerieux Inc recalls GENE-UP Salmonella 2 reagent (Batch 1009407250) after storage temperature and time limits were exceeded, preventing performance guarantee.

    Product
    GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0805-2023·2023-01-11

    Bioball Fungal Reference Standard Recalled for Temperature Storage Issues

    Biomerieux Inc. recalled 2 units of BIOBALL A.BRASILIENSIS NCPF 2275 reference standard (Batch 7112) after temperature and time storage conditions exceeded acceptable ranges. The manufacturer cannot guarantee product performance.

    Product
    BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0850-2023·2023-01-11

    Biomerieux Recalls VITEK 2 Diagnostic Test Kit Due to Storage Conditions

    Biomerieux Inc has recalled the VITEK 2 Reagent AST-GP78 Test Kit nationwide due to temperature and time storage exceedances that may affect product performance. No illnesses or injuries have been reported.

    Product
    VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0800-2023·2023-01-11

    VIDAS Quality Control Product Recalled for Storage Condition Deviation

    Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T nationwide due to storage temperature and time deviations that prevent performance guarantee. Batch 1009351560 is affected.

    Product
    VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0845-2023·2023-01-11

    Laboratory Testing Product Recall Due to Temperature Storage Excursion

    Biomerieux Inc is recalling PPM Lombard Products TSA 3P W Neutralizers due to storage temperature and time excursions that degrade product performance. Affected units cannot guarantee reliable testing results.

    Product
    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014
    Category
    Medical Device
    Distribution
    Distributed nationwide