The Recall Desk

Hazard

Mis Labeling recalls

9,606 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,606
Critical
160
Severe
588
Most recent
2026-09-09

Of the 9,606 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.

301–325 of 9606

  • HighFDA (Devices)·Z-0502-2025·2024-12-04

    Defibtech Defibrillation Pads Mislabeled, Creating Risk of Expired Pads in Use

    Defibtech DDP-100 defibrillation pads distributed in Ireland had authorized labels replaced with unauthorized ones, making expired pads appear fresh. Dried hydrogel on expired pads may fail to deliver adequate energy for cardiac resuscitation.

    Product
    Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0531-2025·2024-12-04

    AMS Artificial Urinary Sphincter Balloon Mislabeled With Wrong Component

    Boston Scientific recalls 52 mislabeled AMS Artificial Urinary Sphincter balloons that may contain a Control Pump instead of the labeled Pressure Regulating Balloon component.

    Product
    AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2025·2024-12-04

    Pediatric defibrillation pads recalled due to labeling and hydrogel degradation

    Defibtech DDP-200P pediatric defibrillation pads distributed in Ireland are recalled due to unauthorized labeling that could make expired pads appear current, and hydrogel drying that may reduce electrical effectiveness.

    Product
    Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0530-2025·2024-12-04

    AMS Artificial Urinary Sphincter Control Pump: Mislabeled Packaging Recall

    Boston Scientific recalled 16 units of AMS Artificial Urinary Sphincter Control Pumps due to mislabeled packaging where devices labeled as Pressure Regulating Balloons actually contained Control Pumps.

    Product
    AMS Artificial Urinary Sphincter Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2025·2024-12-04

    Defibtech Pediatric Defibrillation Pads: Mislabeling and Hydrogel Drying Risk

    Defibtech DDP-2002 pediatric defibrillation pads distributed in Ireland may be mislabeled with unauthorized labels, potentially making expired pads appear current. Hydrogel drying could impair electrical connection and reduce energy delivery during treatment.

    Product
    Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of sudden cardiac arrest (SCA.)
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0557-2025·2024-12-04

    Tempus LS-Manual Defibrillator Recalled for Incorrect Servicing Labels

    Remote Diagnostic Technologies Ltd. is recalling Tempus LS-Manual Defibrillator Model 00-3020 units distributed in eight U.S. states. The devices were labeled incorrectly during servicing with wrong product name and CAT number.

    Product
    Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2025·2024-11-27

    Hip Prosthesis Mislabeled with Wrong Size; Risk of Joint Instability

    Novosource is recalling NovoHip Total Hip System units (lot CER0023) packaged in boxes labeled 32 long but containing 28 long components. If implanted, the wrong size may cause joint instability.

    Product
    NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shel
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0499-2025·2024-11-27

    Cook Incorporated Recalls Approach CTO Micro Wire Guide for Incorrect Expiration Dates

    Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates printed on product labels. Contact the manufacturer for corrected expiration information.

    Product
    Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0490-2025·2024-11-27

    Alcon anti-reflux valve tubing breakage recall due to improper use

    Alcon Research LLC is recalling its Custom-Pak anti-reflux valve tubing because breakage occurred from improper use, resulting in updated labeling requirements.

    Product
    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0139-2025·2024-11-27

    Dietary Supplement Recalled: Douglas Labs Stress-B-Plus Due to Niacin Form Mismatch

    Nestle Health Science is recalling Douglas Labs Stress-B-Plus Dietary Supplement due to incorrect formulation. The product contains Niacin as Nicotinic acid but the label states Niacinamide.

    Product
    Douglas Labs Stress-B-Plus Dietary Supplement, Tablets, 90 tablets per bottle. UPC # 10539 97452, Lot Numbers ,50335944 and 50344396. Expiration Date 04/11/2026
    Category
    Drug
    Distribution
    35 states
  • SevereFDA (Devices)·Z-0357-2025·2024-11-20

    Medline Recalls Non-Sterile Urinalysis Kit Specimen Containers

    Medline Industries is recalling 626,305 urinalysis kits because the specimen containers are labeled sterile but are non-sterile, posing a risk of unnecessary treatment or hospitalization.

    Product
    URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0354-2025·2024-11-20

    Clean Catch Kit specimen containers recalled for sterility labeling failure

    Medline recalls 626,305 Clean Catch Kits whose specimen containers are non-sterile despite sterile labeling, risking specimen contamination and unnecessary treatment.

    Product
    Clean Catch Kit, SKU DYKM1833A; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0132-2025·2024-11-20

    Frozen Potato Wedges Recalled for Undeclared Wheat Allergen

    JR Simplot's frozen seasoned potato wedges are being recalled because the product contains wheat but the label does not declare this allergen. The affected product was distributed to retailers in Pennsylvania only.

    Product
    Item #473015 Simplot seasoned CRISP Delivery+ Savory 6 Cut Crinkle Cut Wedge, Frozen Potatoes, 5lb. bag without any labeling, 6 bags per case, SKU 10071179473015. Packaging Distribution Information: J.R. Simplot Company P.O. Box 9386, Boise, ID 83707. Ingredients: POTATOES, VEGE
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·24C001000·2024-11-19

    Britax Recalls One4Life Slim ClickTight Car Seats Due to Labeling Error

    Britax is recalling specific One4Life Slim ClickTight car seats because incorrect labels and user guides state the wrong maximum rear-facing weight, potentially leading to improper installation.

    Product
    CHILD SEAT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0104-2025·2024-11-13

    Aunt Millie's Bakehouse Hot Dog Buns Recalled for Undeclared Sesame Allergen

    Perfection Bakeries LLC is recalling Aunt Millie's Bakehouse Whole Grain White Hot Dog Buns for containing undeclared sesame. Approximately 10,987 cases distributed across multiple states.

    Product
    Aunt Millie s Bakehouse Whole Grain White Hot Dog Buns 6" Sliced 2 OUNCE. 12 unlabeled 12CT PKGS per sale unit case, product code 7502. Net. Wt. 18lbs.
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0121-2025·2024-11-13

    Kirkland Signature Unsalted Butter Recalled for Missing Milk Allergen Label

    Kirkland Signature Unsalted Sweet Cream Butter is being recalled because the label lists cream as an ingredient but is missing the required 'Contains Milk' allergen statement. Consumers with milk allergies should not consume this product.

    Product
    Kirkland Signature Unsalted Sweet Cream Butter, Net Wt 16 oz (1 lb) 453g, Four 4 oz (113g) sticks UPC 96619-38496.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0122-2025·2024-11-13

    Kirkland Signature Butter Recalled for Missing Milk Allergen Statement

    Kirkland Signature Salted Sweet Cream Butter is being recalled because the packaging may lack the required 'Contains Milk' allergen warning. Consumers with milk allergies who purchased this product in Texas should not consume it.

    Product
    Kirkland Signature Salted Sweet Cream Butter, Net Wt 16 oz (1 lb) 453g, Four 4 oz (113g) sticks UPC 96619-38488.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-0288-2025·2024-11-13

    iotaSOFT Plus Drive Unit Recalled Due to Incorrect GTIN Number

    Iotamotion Inc. is recalling the iotaSOFT Plus Drive Unit (Lot #D500330) due to an incorrect GTIN number on the product label. Five devices were distributed in Iowa.

    Product
    iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateNHTSA·24V852000·2024-11-08

    Air Bag Warning Label Missing on Ford and Lincoln Vehicles

    Ford is recalling certain 2018-2025 Ford and Lincoln vehicles for missing air bag warning labels on the dashboard. The missing label increases risk of crash injury if occupants don't follow proper restraint guidelines.

    Product
    FORD — FORD, LINCOLN EXPLORER, CORSAIR, AVIATOR, F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2025·2024-11-06

    Thyroglobulin Antibody Assay Instructions Incorrectly State Biotin Interference Resolution

    Beckman Coulter is recalling over 465,000 thyroglobulin antibody test kits because their instructions incorrectly state that biotin interference was addressed. The false information could lead to false-low test results.

    Product
    Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0260-2025·2024-11-06

    Surgical tracking device patient labels show incorrect expiration date

    Patient label stickers on Insight Base Flex tracking device snaps have incorrect expiration dates. The stickers show manufacturing date instead of actual expiration date, though the correct date appears on carton and pouch labels.

    Product
    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0258-2025·2024-11-06

    17-OH Progesterone ELISA Kit Recalled for Labeling Discrepancy

    DRG International is recalling 504 units of its 17-OH Progesterone ELISA kit (Model EIA-1292) due to mismatched control acceptance ranges between the Certificate of Analysis and component labels, causing test failure.

    Product
    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0070-2025·2024-11-06

    International Delight Peppermint Mocha Mislabeled as Zero Sugar Product Recall

    DANONE US LLC is recalling Home Alone International Delight Peppermint Mocha Zero Sugar beverages because the product is labeled as zero sugar but actually contains sugar. The recall affects 1,799 cases distributed across multiple states.

    Product
    Home Alone International Delight Peppermint Mocha Zero Sugar, 32oz plastic bottle, 6 bottles per case. Refrigerated.
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-0225-2025·2024-10-30

    Endoscopic Dilation Balloon Mislabeled with Incorrect Size Information

    Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.

    Product
    EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0220-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrode recalled for MRI safety label discrepancy

    Ad-Tech is recalling A-style depth electrodes due to incorrect MRI safety labeling. Devices were labeled as MR Conditional when they should be labeled MR Unsafe.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide