The Recall Desk

Hazard

Performance Defect recalls

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

What the numbers show

Total
82
Critical
0
Severe
0
Most recent
2026-05-06

Of the 82 performance defect 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 defect 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 82

  • ModerateFDA (Devices)·Z-1982-2026·2026-05-06

    BD GasPak EZ CO2 Pouch System gas generating sachets underperforming

    Becton Dickinson is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification.

    Product
    BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1983-2026·2026-05-06

    BD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production

    Becton Dickinson & Co. is recalling certain lots of BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification, potentially affecting microbiologic laboratory testing.

    Product
    BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2050-2025·2025-07-09

    Philips C5-2 Ultrasound Transducers Refurbished Beyond Useful Life

    Philips Ultrasound, Inc. is recalling Philips C5-2 Transducers because they were refurbished beyond their useful life. The affected devices were distributed domestically nationwide and internationally across 49 countries.

    Product
    Philips C5-2 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1947-2025·2025-06-18

    Thermo SCIENTIFIC Sensititre Mueller-Hinton Broth diagnostic device recalled

    Remel, Inc. is recalling one lot of Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth due to off-color that may affect performance of this in-vitro diagnostic device.

    Product
    Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1576-2025·2025-04-23

    ID NOW RSV 24T Respiratory Virus Panel Has Higher Invalid Test Rates

    Abbott Diagnostics is recalling specific lots of the ID NOW RSV 24T respiratory virus assay due to higher-than-expected invalid test rates. The affected lots were distributed nationwide.

    Product
    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2025·2025-04-23

    ID NOW COVID-19 2.0 Point-of-Care Test Device Recall

    Abbott is recalling certain lots of the ID NOW COVID-19 2.0 24T test device due to higher invalid result rates than stated in product instructions. The affected lots were distributed worldwide.

    Product
    Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2025·2025-04-23

    ID NOW Influenza A/B 2 24T Diagnostic Assay Invalid Result Rates

    Abbott Diagnostics is recalling certain lots of the ID NOW Influenza A/B 2 24T diagnostic assay due to higher-than-expected invalid test result rates. Affected lots were distributed worldwide.

    Product
    Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness

    Alcon is recalling 4,481 units of ClearCut and A-OK brand ophthalmic surgical knives due to complaint reports of inadequate sharpness. These instruments are used in eye surgery and may not perform as intended.

    Product
    Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2023·2023-03-29

    Cardiosave IABP Safety Disk Model 0202-00-0140 Recalled for Performance Defect

    Datascope Corp. is recalling 669 Cardiosave IABP Safety Disks due to a performance defect that may reduce balloon inflation during cardiac support therapy. The affected devices may not provide adequate augmentation to patients requiring mechanical circulatory support.

    Product
    Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0785-2023·2023-01-11

    API 20 C AUX Diagnostic Strips Recalled Due to Storage Temperature Exceedance

    Biomerieux Inc is recalling API 20 C AUX diagnostic strips due to storage conditions that exceeded temperature and time specifications. The manufacturer cannot guarantee product performance.

    Product
    API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2021·2021-09-22

    Leica BOND Primary Antibody CDX2 Recalled for Performance Specification Issue

    Leica Microsystems recalls BOND Ready-To-Use Primary Antibody CDX2 (PA0375, Lot 69909) because the product may not perform as specified in its instructions for use. The recall affects 237 units distributed nationwide.

    Product
    BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1561-2021·2021-05-19

    Remel Bile Esculin Azide Agar Recalled for Growth of E. faecalis

    Remel Inc is recalling Bile Esculin Azide Agar with Vancomycin because the media allows growth of E. faecalis ATCC 29212.

    Product
    Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2021·2020-11-25

    Ortho Recalls VITROS SARS-CoV-2 IgG Calibrators Due to Elevated Signal Values

    Ortho Clinical Diagnostics is recalling specific lots of VITROS SARS-CoV-2 IgG Calibrators because they produced elevated signal values. The recall also includes one lot of IgG Controls with decreased signal.

    Product
    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized labora
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0451-2021·2020-11-25

    Ortho Recalls VITROS Anti-SARS-CoV-2 IgG Control Due to Signal Issues

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Control and Calibrator lots due to elevated signal/cutoff values and decreased signal.

    Product
    VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 61999
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3033-2020·2020-10-07

    Ameditech Recalls Consult Diagnostics Drugs Abuse Test Cups

    Ameditech Inc is recalling 31,600 units of Consult Diagnostics Drugs Abuse Test Cups because immunoassay enzymes failed performance tests, leading to inconsistent detection of compounds.

    Product
    Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2367-2020·2020-06-24

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier II

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier II units because multiple coatings of AMYL Slides show imprecision on control fluids.

    Product
    VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0744-2020·2020-01-01

    Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues

    Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential performance issues detected during routine testing.

    Product
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0652-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation System

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0413-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is removing N-proBNP claims from Liquid Cardiac Controls due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Number CQ5052.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0377-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometric Design Defect

    Orthofix Srl is recalling specific lots of 3.2 mm drill bits because a geometric detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0384-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0383-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometric Design Deviation

    Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometric detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0401-2020·2019-11-20

    Orthofix Ankle Transfix Pin Sterile Kit Recalled for Design Defect

    Orthofix Srl is recalling Ankle Transfix Pin Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0390-2020·2019-11-20

    Orthofix Recalls Prefix II Diaphyseal Complete Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Diaphyseal Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0389-2020·2019-11-20

    Orthofix Recalls UE Xcaliber Ankle Complete Kits Due to Drill Bit Design Flaw

    Orthofix Srl is recalling UE Xcaliber Ankle Complete Kits because drill bits have a design flaw that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
    Category
    Medical Device
    Distribution
    29 states