The Recall Desk

Hazard

Mis Labeling recalls

9,607 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,607
Critical
160
Severe
588
Most recent
2026-09-10

Of the 9,607 mis labeling recalls we have scored against our rubric, 160 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 588 (6%) 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 mis labeling 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.

1726–1750 of 9607

  • LowFDA (Devices)·Z-0409-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 18 units of the SynMesh Cage System because the statutory label incorrectly identified the device as a 'general medical device' instead of a 'specially controlled medical device.'

    Product
    END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0406-2021·2020-11-11

    Synthes Recalls SYN MESH Cages Due to Incorrect Labeling

    Synthes (USA) Products LLC is recalling 9 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical device' instead of 'specially controlled medical device.'

    Product
    SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suit
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0405-2021·2020-11-11

    Synthes SYN MESH Vertebral Body Replacement Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 17 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical devices' instead of 'specially controlled medical devices.'

    Product
    SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0408-2021·2020-11-11

    Synthes SynMesh Cages Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 16 SynMesh Cages distributed in Japan because the statutory label incorrectly identified them as general medical devices.

    Product
    END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0410-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 23 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'

    Product
    END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0411-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 9 units of the SynMesh Cage System because the statutory label incorrectly identifies the device as a 'general medical device' rather than a 'specially controlled medical device.'

    Product
    END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration th
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0407-2021·2020-11-11

    Synthes SYNMesh Vertebral Body Replacement Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 5 units of SYNMesh vertebral body replacement devices because the statutory label incorrectly identifies them as general medical devices.

    Product
    SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best sui
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0417-2021·2020-11-11

    Synthes SynMesh Cages Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 18 units of SynMesh Cages due to incorrect statutory labeling. The devices were distributed only in Japan.

    Product
    3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suit
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0403-2021·2020-11-11

    DePuy Synthes SYNMESH CAGE System Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 10 units of DePuy Synthes SYNMESH CAGE System devices distributed in Japan due to incorrect statutory labeling.

    Product
    DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0416-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 6 units of the SynMesh Cage System because the statutory label incorrectly identified the device as a 'general medical device' instead of a 'specially controlled medical device.'

    Product
    STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to t
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0292-2021·2020-11-04

    Pentax 9372HD Digital Capture Software Recall for Patient Data Error

    Pentax of America Inc. is recalling 39 units of the 9372HD Digital Capture system due to a software issue that may copy exam videos to the wrong patient.

    Product
    9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0288-2021·2020-11-04

    Blue Ortho Recalls GPS Tracker Instructions Due to Sterilization Language

    Blue Ortho is recalling 3,471 GPS Tracker Instructions For Use documents because some low-temperature sterilization conditions were approved based on rational documents.

    Product
    Instructions For Use document of the GPS Trackers.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0308-2021·2020-11-04

    Exactech Recalls Equinoxe Platform Fracture Stem Due to Incorrect Laser Marking

    Exactech is recalling 12 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems when they are left stems.

    Product
    Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0303-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Due to Incorrect Strain

    Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units because the product was confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0307-2021·2020-11-04

    Exactech Recalls Equinoxe Platform Fracture Stem Due to Incorrect Laser Marking

    Exactech is recalling 25 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems instead of left stems.

    Product
    Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0302-2021·2020-11-04

    Jarrow Formulas Recalls N-A-C Capsules Due to Mislabeling

    Jarrow Formulas is recalling 533 units of N-A-C 500 mg capsules because they were mislabeled as a different product.

    Product
    N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0304-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK 2 Pack Due to Incorrect NDM-1 Strain

    Microbiologics Inc is recalling KWIK-STIK 2 Pack units where the NDM-1 positive strain was confirmed to be negative.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0302-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Culture Units

    Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units that were confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or f
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0026-2021·2020-10-28

    Marketside Cranberry Walnut Salad Recalled for Undeclared Wheat and Walnuts

    Taylor Farms is recalling Marketside Cranberry Walnut Salad because the ingredient statement fails to declare wheat and walnuts.

    Product
    Marketside brand Cranberry Walnut Salad in 4.5 oz. plastic bowl with poly film lidding (6 bowls per case). UPC: 583243601
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0115-2021·2020-10-28

    Siemens Recalls HER-2/neu Assay Kits Due to Inaccurate Results

    Siemens Healthcare Diagnostics is recalling specific HER-2/neu assay kits and calibrators because the Upper Limit of Normal was not achieved, potentially causing false positive or negative results.

    Product
    Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)0063041459916
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0040-2021·2020-10-28

    Killz Germz Hand Sanitizer Recalled for Sub-Potent Alcohol Levels

    Genesis Partnership Company SA is recalling Killz Germz Hand Sanitizer because testing showed ethanol levels as low as 62%, below the labeled 70% claim.

    Product
    Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0124-2021·2020-10-28

    Quidel Recalls Sofia SARS Antigen FIA Package Inserts for Labeling Errors

    Quidel Corporation is recalling package inserts for the Sofia SARS Antigen FIA test because instructions referencing specific viral transport media may lead to false-positive results.

    Product
    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2021·2020-10-28

    Encore Medical Recalls Mislabeled AltiVate Shoulder Socket Inserts

    Encore Medical is recalling 15 AltiVate Reverse Small Socket Inserts due to mislabeling. The error may cause surgery delays or the need for revision surgery.

    Product
    AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide