The Recall Desk

Hazard

Mislabeling recalls

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

What the numbers show

Total
395
Critical
20
Severe
45
Most recent
2026-07-22

Of the 395 mislabeling recalls we have scored against our rubric, 20 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (11%) 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 mislabeling 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 395

  • ModerateFDA (Devices)·Z-2732-2026·2026-07-22

    Orthofix MINIRAIL External Fixation Devices Incorrectly Labeled

    Orthofix MINIRAIL unilateral external fixation devices may be labeled with incorrect model numbers. Three model variants (M101, M103, M122) were mislabeled during manufacturing.

    Product
    Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·H-1143-2026·2026-07-15

    Bakr Brown Butter Chocolate Chunk Cookie Dough Recalled for Undeclared Soy

    Bear Stewart Co is recalling Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough due to undeclared soy. The product was distributed in Southern California, Southern Nevada, Arizona, and Utah through Target stores.

    Product
    Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough, 8-oz pouch 12 cookies per pouch, UPC 8 50073 08700 8, 8 pouches per case
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·H-1146-2026·2026-07-15

    Wise Onion Rings recalled for undeclared food color additives

    Wise Foods Inc is recalling Wise Onion Rings, 3.75 oz packages, because they contain undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3 food colorings that are not listed on the label.

    Product
    Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case,
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2308-2026·2026-06-10

    Stapes prosthesis pistons carry an incorrect functional length on labeling

    Titanium/fluoroplastic piston stapes prostheses are being recalled because the device labeling states an incorrect functional length. Seven units are affected.

    Product
    TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2026·2026-06-03

    Medline eye trays contain insulin syringes labeled as tuberculin syringes

    Medline EYE TRAY-LF kits are being recalled because they contain Cardinal Health syringes packaged as 1 mL tuberculin syringes but which are actually U-100 insulin syringes.

    Product
    Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2026·2026-06-03

    HydroMARK breast biopsy markers may carry the wrong inner labeling

    HydroMARK Breast Biopsy Site Markers are being recalled because boxes labeled as T3 markers may contain individual packages labeled as T4 markers. 1,910 units are affected.

    Product
    HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2047-2026·2026-05-20

    Omnicell i.v.Station label stock rolls for syringe preparation

    Omnicell is recalling rolls of label stock used in the i.v.Station automation device due to potential for mislabeled syringes during IV medication preparation and compounding.

    Product
    Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automat
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·H-0712-2026·2026-05-13

    French Broad chocolate assortment tasting guide misidentifies walnut bonbons

    French Broad Chocolate bette's bake sale bonbon assortments are being recalled because the printed tasting guide misidentifies the Walnut Fudge and Peach Cobbler chocolates.

    Product
    french broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment). 6-piece NET WT. 2.5 OZ (70.75G); 12-piece NET WT. 5 OZ (141.75G); and 24-piece NET WT. 10 OZ (283.5G), French Broad Chocolate Crafted in Asheville, NC 28801, USA
    Category
    Food
    Distribution
    41 states
  • HighFDA (Devices)·Z-1940-2026·2026-04-29

    Diversatek Viper balloon dilator tags may show incorrect inflation parameters

    Diversatek Viper 3-Stage Wire Guided Balloon Dilators are being recalled because the catheter inflation tag may show an incorrect part number with wrong balloon diameters and pressures.

    Product
    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·H-0681-2026·2026-04-22

    Pure Palm Medjool dates packaging carries the wrong product label

    Pure Palm Medjool Dates are being recalled because coconut-covered date bites were packed in containers labelled for regular date bites. 50 cases are affected.

    Product
    Label is predominantly green with white lettering in a clear plastic clamshell container. Pure Palm dates- Medjool Dates Net Wt. 16OZ UPC: 852160007005
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1790-2026·2026-04-15

    Cook Medical chest tube tray labeled with an overstated expiration date

    Cook Medical is recalling Thal-Quick Chest Tube Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. Two units are affected.

    Product
    COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1782-2026·2026-04-15

    Cook Medical extubation set labeled with an overstated expiration date

    Cook Medical is recalling Staged Extubation Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 95 units are affected.

    Product
    COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1786-2026·2026-04-15

    Cook Medical multipurpose drainage catheters carry overstated expiration dates

    Cook Medical is recalling a Multipurpose Drainage Catheter because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.

    Product
    COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1783-2026·2026-04-15

    Cook Medical Spectrum central venous catheter trays carry overstated expiration dates

    Cook Medical is recalling custom Spectrum Central Venous Catheter Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 1,872 units are affected.

    Product
    COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G3
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1789-2026·2026-04-15

    Cook Medical Spectrum central venous trays carry overstated expiration dates

    Cook Medical is recalling Spectrum Central Venous Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 2,348 units are affected.

    Product
    COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1778-2026·2026-04-15

    Cook Medical arterial pressure monitoring trays carry overstated expiration dates

    Cook Medical is recalling Arterial Pressure Monitoring Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.

    Product
    COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1776-2026·2026-04-15

    Cook Medical micro wire guides labeled with overstated expiration dates

    Cook Medical is recalling Approach CTO-12 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.

    Product
    COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0652-2026·2026-04-15

    Zarlengo's Double Dark Chocolate Gelato recalled for undeclared soy allergen

    Zarlengo Italian Ice is recalling Zarlengo's Double Dark Chocolate Gelato in 1-gallon buckets because soy lecithin is listed in the ingredients but soy is not disclosed in the allergen statement, posing a risk to consumers with soy allergies.

    Product
    Zarlengo's Double Dark Chocolate Gelato packaged in 1 Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1779-2026·2026-04-15

    Blue Rhino G2-Multi tracheostomy introducer sets carry overstated expiration dates

    Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 916 units are affected.

    Product
    COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Refer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1784-2026·2026-04-15

    Cook Medical bile duct exploration sets labeled with overstated expiration dates

    Cook Medical is recalling the Strange Bile Duct Stone Exploration Set because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.

    Product
    COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1781-2026·2026-04-15

    Cook Medical tracheostomy introducer sets labeled with overstated expiration dates

    Cook Medical is recalling Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 484 units are affected.

    Product
    COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1777-2026·2026-04-15

    Cook Medical CTO-18 wire guides labeled with overstated expiration dates

    Cook Medical is recalling Approach CTO-18 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 75 units are affected.

    Product
    COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1785-2026·2026-04-15

    Cricothyrotomy catheter sets labeled with overstated expiration dates

    Cook Incorporated is recalling Melker Universal Cuffed Emergency Cricothyrotomy Catheter Sets because affected lots were labeled with expiration dates that exceed the true shelf life.

    Product
    Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1792-2026·2026-04-15

    Cook Medical pneumothorax tray labeled with an overstated expiration date

    Cook Medical is recalling Wayne Pneumothorax Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 318 units are affected.

    Product
    COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Par
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1791-2026·2026-04-15

    Cook Medical Wayne pneumothorax sets carry overstated expiration dates

    Cook Medical is recalling Wayne Pneumothorax Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 104 units are affected.

    Product
    COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
    Category
    Medical Device
    Distribution
    0 states