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.

2076–2100 of 9607

  • HighFDA (Devices)·Z-1752-2020·2020-04-29

    Beckman Coulter Recalls Opiate 300 Ng Reagent Due to Cross-Reactivity Issues

    Beckman Coulter is recalling Opiate 300 Ng Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative urine test results.

    Product
    Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1743-2020·2020-04-29

    Fentanyl Reagent Kit Recalled for Mislabeling as Clinical Diagnostic

    Carolina Liquid Chemistries Corp is recalling Fentanyl Reagent Kits sold to clinical labs without FDA clearance. The products were mislabeled for diagnostic use but are intended for forensic use only.

    Product
    Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1728-2020·2020-04-29

    Abbott Recalls Architect HAVAB G Reagent Kits Due to Antigen Concentration Error

    Abbott is recalling 7,347 Architect HAVAB G Reagent Kits because an erroneous concentration value was used during manufacture, resulting in a decreased amount of antigen.

    Product
    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1753-2020·2020-04-29

    Rayner RaySert PLUS Intraocular Lens Injector Recall for Labeling Error

    Rayner Intraocular Lenses Limited is recalling RaySert PLUS RSP01 injectors due to a mismatch between the outer and inner tray expiration dates and lot numbers.

    Product
    RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved label
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1697-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 40 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0907-2020·2020-04-22

    Dana USA Recalls Dried Mushrooms for Undeclared Sulfites

    Dana USA Corp. is recalling DION DION Dried Mushrooms because the product label fails to declare sulfites.

    Product
    DION DION DRIED MUSHROOMS, Product Origin from Haiti, Net Wt. 1/4 oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1705-2020·2020-04-22

    Life Technologies Recalls Oncomine Dx Target Test RNA Control for Expiration Date Error

    Life Technologies is recalling 66 units of the Oncomine Dx Target Test RNA Control because the expiration date was extended prior to regulatory clearance.

    Product
    Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1696-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 118 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1704-2020·2020-04-22

    Life Technologies Recalls Oncomine Dx Target Test DNA Control-IVD

    Life Technologies is recalling 66 units of Oncomine Dx Target Test DNA Control-IVD because the expiration date was extended prior to clearance.

    Product
    Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1706-2020·2020-04-22

    Life Technologies Recalls Oncomine Dx Target Test Due to Expiration Date Error

    Life Technologies is recalling 35 units of the Oncomine Dx Target Test because the expiration date was extended prior to clearance.

    Product
    Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1702-2020·2020-04-22

    Merit Medical Recalls Nonsterile ChloraPrep Applicators for Vein Trays

    Merit Medical Systems is recalling six units of nonsterile ChloraPrep applicators that were inadvertently shipped to a customer in Illinois.

    Product
    ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1698-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 43 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1707-2020·2020-04-22

    Life Technologies Recalls Ion Torrent Dx No Template Control Kit

    Life Technologies is recalling 79 units of the Ion Torrent Dx No Template Control Kit due to extended expiration dates prior to clearance.

    Product
    Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1713-2020·2020-04-22

    CooperSurgical Recalls Wallace Catheters Due to Expiration Date Error

    CooperSurgical is recalling Wallace Artificial Insemination Catheters because the expiration date was marked as 5 years instead of 3 years.

    Product
    Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1695-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 110 Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1131-2020·2020-04-15

    FDA Recalls Hernia Off for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Hernia Off because the product is misbranded as an unapproved new drug.

    Product
    Hernia Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1140-2020·2020-04-15

    Herbal Doctor Remedies Recalls Lipidtrol Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Lipidtrol 500mg capsules because the products were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Lipidtrol, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1174-2020·2020-04-15

    Herbal Doctor Remedies Recalls Thyro-H Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Thyro-H 500mg capsules because the products were found to be misbranded as unapproved new drugs.

    Product
    Thyro-H, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1133-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes Off Due to Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Herpes Off because the product is misbranded as an unapproved new drug. The product was sold online in the U.S. and internationally.

    Product
    Herpes Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1121-2020·2020-04-15

    Dragon Pain Balm Recalled for Being an Unapproved New Drug

    Herbal Doctor Remedies is recalling Dragon Pain Balm because it is misbranded as an unapproved new drug. The product was sold online in the US and internationally.

    Product
    Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-0882-2020·2020-04-15

    Audrey's Chia Cookies Peanut Butter Recalled for Undeclared Milk Allergen

    Health Harvest, LLC is recalling Audrey's Chia Cookies Peanut Butter because the product contains undeclared milk, a major food allergen.

    Product
    Audrey's Chia Cookies Peanut Butter, 4 OZ flexible pouch packaging, UPC Code: 858652007034, Manufactured for Health Harvest, LLC, P.O. Box 20634, Mesa, AZ 85277. 12 pouches/case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-1116-2020·2020-04-15

    Herbal Doctor Remedies Recalls Dermamycin Capsules for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Dermamycin 500mg capsules because the products are misbranded as unapproved new drugs.

    Product
    Dermamycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states