The Recall Desk

Hazard

Mis Labeling recalls

9,610 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,610
Critical
161
Severe
588
Most recent
2026-09-16

Of the 9,610 mis labeling recalls we have scored against our rubric, 161 (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.

6051–6075 of 9610

  • ModerateFDA (Devices)·Z-0267-2016·2015-11-18

    Biomet 3i Dental Driver Tip Recalled for Mislabeling

    Biomet 3i is recalling 103 Narrow Right Angle Square Driver Tips that were mislabeled as hexed tips, creating a risk of improper use during dental procedures.

    Product
    Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0252-2016·2015-11-18

    Biocare Medical Recalls Smooth Muscle Actin Immunohistochemistry Reagents

    Biocare Medical is recalling certain lots of Smooth Muscle Actin reagents because they may stain cell types that should be negative.

    Product
    Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0239-2016·2015-11-18

    Beckman Coulter Recalls Access CEA Assay Reagent Packs for Filling Errors

    Beckman Coulter is recalling Access CEA Assay reagent packs because they were filled incorrectly. The recall covers 11,406 units distributed worldwide.

    Product
    Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0253-2016·2015-11-18

    CooperSurgical Recalls MILEX Pessary Kits Due to Incorrect Packaging Labels

    CooperSurgical is recalling 144 MILEX Pessary Kits because the outer packaging displays incorrect size prints, although the pessary pouch itself is correctly marked.

    Product
    MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2016·2015-11-11

    Alcon Custom Pak 9319-27 Recalled for Latex Glove Mislabeling

    Alcon Research, Ltd. is recalling five units of Custom Pak 9319-27 ophthalmic surgical devices because they contain latex gloves despite being labeled as latex-free.

    Product
    Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0147-2016·2015-11-11

    Peeled Mote Corn Recalled for Unlabeled Sulfites

    JP Trading and Global Imports LLC is recalling 80 cases of Tradiciones Andinas Peeled Mote Corn because the product contains sulfites that are not listed on the label.

    Product
    Tradiciones Andinas Gourmet Foods Peeled Mote Corn, Mote Pelado, Net Wt. 15 oz. (425g), Product of Peru, Distributed By: JP Trading and Global Imports LLC, Newark NJ 07102
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0203-2016·2015-11-11

    Biomet Spine Recalls MaxAn Cervical Spine Screws Due to Labeling Error

    Biomet Spine is recalling 17 MaxAn cervical spine screws because 4.5 mm units were mislabeled as 4.0 mm.

    Product
    MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0231-2016·2015-11-11

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly where user-modified parameters revert to default values during ADD installation.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0198-2016·2015-11-11

    C.R. Bard Recalls Antibacterial Hydro Personal Catheters Due to Labeling Error

    C.R. Bard is recalling 4,170 units of Antibacterial Hydro Personal Catheters because the unit label may incorrectly state the product code and size.

    Product
    Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V741000·2015-11-09

    Forest River Surveyor Recalled for Incorrect Federal Certification Placard Tire Size

    Forest River is recalling 2010-2016 Surveyor recreational trailers because the Federal Certification Placard lists incorrect tire and rim sizes, which may lead to poor handling if incorrect tires are installed.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·137-2015·2015-11-06

    Athens Foods Recalls Beef Products Due to Undeclared Soy Allergen

    Athens Foods is recalling approximately 168 pounds of beef products because they contain undeclared soy, a known allergen. No adverse reactions have been reported.

    Product
    Athens Foods, Inc. — Athens Foods, Inc. Recalls Beef Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0097-2016·2015-11-04

    Trader Joe's Coconut Cranberry Granola Recalled for Undeclared Allergens

    New England Natural Bakers is recalling Trader Joe's Coconut Cranberry Granola because it may contain undeclared milk, wheat, and pecans.

    Product
    Trader Joes Coconut Cranberry Granola (SKU 51131), packaged in a 16 oz. box, with Best By date 08/19/16 printed at the top of the package UPC Code: 0051 1315 printed on side panel.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0107-2016·2015-11-04

    Kermit's P4 Hot Sauce Recalled for Undeclared Soy Allergen

    Kermit, Inc. is recalling Kermit's P4 Hot Sauce because the product label fails to declare soy, a major food allergen.

    Product
    Kermit's P4 Hot Sauce, 5.5 oz, Key West, FL, UPC 020108012019 & 802468905701
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2016·2015-11-04

    Siemens ADVIA Chemistry XPT Systems Recalled for Unflagged Electrode Errors

    Siemens is recalling ADVIA Chemistry XPT systems because unplugged electrodes may cause unflagged errors in sodium, potassium, or chloride results.

    Product
    ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0121-2016·2015-11-04

    American Pure Whey Protein Recalled for Undeclared Soy and Milk Allergens

    American Pure Whey is recalling Whey Protein Matrix Vanilla flavor due to undeclared soy and milk allergens.

    Product
    American Pure Whey, Whey Protein Matrix Vanilla flavor, 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC.
    Category
    Food
    Distribution
    28 states
  • HighFDA (Food)·F-0105-2016·2015-11-04

    Kermit's Hot & Spicy Key Lime Barbecue Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 16 oz bottles of Hot & Spicy Key Lime Barbecue Sauce due to undeclared soy on the label.

    Product
    Kermit's Hot & Spicy Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 116601501423 & 802468905312
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0106-2016·2015-11-04

    Kermit's Chipotle Key Lime Barbecue Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 16 oz bottles of Chipotle Key Lime Barbecue Sauce due to undeclared soy on the label.

    Product
    Kermit's Chipotle Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 091920850929
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0102-2016·2015-11-04

    Kermit's Key Lime Steak Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 10-ounce bottles of Key Lime Steak Sauce because the label fails to list soy as an ingredient.

    Product
    Kermit's Key Lime Steak Sauce, 10 oz, Key West, FL, UPC 231920085093
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2016·2015-11-04

    Perkin Elmer Specimen Gate Software Recall for Incorrect Result Interpretation

    Perkin Elmer is recalling Specimen Gate software because abnormal newborn screening test results may be incorrectly interpreted as normal.

    Product
    Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0101-2016·2015-11-04

    Kermit's Key Lime Cocktail Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 12-ounce bottles of Key Lime Cocktail Sauce due to undeclared soy on the label.

    Product
    Kermit's Key Lime Cocktail Sauce, 12 oz, Key West, FL, UPC 007172006076 & 0802468905503
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0103-2016·2015-11-04

    Kermit's Key Lime Barbecue Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 16 oz bottles of Key Lime Barbecue Sauce due to undeclared soy on the label.

    Product
    Kermit's Sweet & Tasty Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 011550150134 & 802468905411
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0110-2016·2015-11-04

    Sobisk Lemon Cream Cookies Recalled for Undeclared Color Additive

    Sobisk Foods LLC is recalling Lemon Cream Cookies imported from India because they contain undeclared FD & C Yellow #5.

    Product
    Sobisk Lemon Cream Cookies; Imported Exclusively by: Sobisk Foods, LLC, 110 W Baltimore Ave, Clifton heights, PA 19018; Product of India;;; BEST BY: 1/31/2017 Net Wt: 11.04 oz package 10 Packs and/or Net Wt: 9.1 oz. 8 Packs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0167-2016·2015-11-04

    Synthes 2.7 mm Locking Screws Recalled for Mislabeling as 2.4 mm

    Synthes (USA) Products LLC is recalling 98 units of 2.7 mm locking screws that were mislabeled as 2.4 mm. The units were distributed to Tennessee.

    Product
    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0165-2016·2015-11-04

    Encore Medical Recalls Exprt Precision System Knee Implants for Missing Labeling

    Encore Medical is recalling 209 Exprt Precision System Revision Knee implants because the labeling is missing size and diameter information.

    Product
    Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
    Category
    Medical Device
    Distribution
    13 states