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.

3151–3175 of 9607

  • ModerateFDA (Devices)·Z-0402-2019·2018-11-14

    DT MedTech Recalls Ankle Joint Inlays Due to Incorrect Package Labeling

    DT MedTech is recalling 54 units of Hintermann Series H3 Poly Inlays because the package labeling incorrectly identifies the device.

    Product
    DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0217-2019·2018-11-14

    Janssen Recalls Ortho-Novum 1/35 Due to Incorrect Dispenser Instructions

    Janssen Pharmaceuticals is recalling Ortho-Novum 1/35 tablets because the packaging included instructions for the wrong type of pill dispenser.

    Product
    Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0410-2019·2018-11-14

    R&D Systems Recalls Vitamin D ELISA Kits Due to Labeling Error

    R&D Systems is recalling eight Human Total 25-OH Vitamin D IVD ELISA Kits because they were shipped without lot-specific booklets and contained a calibrator vial with an incorrect reconstitution volume label.

    Product
    R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0389-2019·2018-11-14

    Medtest AutoHDL/LDL Cholesterol Calibrator Recalled for Missing Vial Labels

    Medtest Holdings is recalling 22 vials of AutoHDL/LDL Cholesterol Calibrator shipped without labels in five states.

    Product
    Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0342-2019·2018-11-07

    Houlihan's Creamy Garlic Ranch Dressing Recalled for Undeclared Milk Allergen

    CFS West Holdings Inc. is recalling 293 cases of Houlihan's Creamy Garlic Ranch Dressing that may be mislabeled as Horseradish Sauce, failing to declare the milk allergen.

    Product
    Houlihan's Creamy Garlic Ranch Dressing potentially labeled as Horseradish Sauce, 1 gal containers Mfg. exclusively for: Houlihan's Restaurant, Inc. Leawood, KS
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0350-2019·2018-11-07

    Apollo Food Mini Rolls Recalled for Undeclared Eggs

    Apollo Food International Inc. is recalling Mini Rolls due to undeclared eggs. The product was distributed in Massachusetts, New York, and New Jersey.

    Product
    Mini Roll, The product comes in a 2.469 ounce pink plastic package marked with a production date of 2018.03.20 stamped on the back. The product UPC code is 6 946050 104746. Product of China.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0285-2019·2018-11-07

    Magellan LeadCare II Blood Lead Test Kit Recalled for Calibration Defect

    Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because a calibration defect causes all patient results to display as HIGH.

    Product
    Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0303-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling 145 CT scanners because software version 4.2.0 generates confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0349-2019·2018-11-07

    Melissa's Hatch Chile Clean Snax Recalled for Missing Peanut Allergen Labeling

    World Variety Produce is recalling Melissa's Hatch Chile Clean Snax because peanuts are listed in ingredients but not in the allergen information.

    Product
    Melissa's Hatch Chile Clean Snax, with Chia and flaxseed; 6.5 oz. plastic clamshell tub. Ingredients: Peanuts, Almonds, Cashews, Flaxseed, White Sesame Seeds, Evaporated Cane Juice, Green Match Chile Powder, Chia Seeds, Rice Syrup (Rice, Rice Milk Water), S=Honey, Sea, Salt.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2019·2018-11-07

    Philips IQon Spectral CT Software Recall for Misleading Calcium Score Reports

    Philips is recalling IQon Spectral CT scanners with specific software versions because the Calcium Score report provides confusing and potentially misleading plaque analysis data.

    Product
    IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0353-2019·2018-11-07

    Vosges Haut-Chocolat Caramels et Chocolats Recalled for Wheat Labeling Error

    Vosges Haut-Chocolat is recalling Caramels et Chocolats because the outer packaging fails to declare wheat, although the inner packaging does.

    Product
    Caramels et Chocolats. Each retail tube contains four varieties on chocolate bonbons. Net wt per tube 3.8 oz.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0075-2019·2018-11-07

    Foodstirs Organic Mug Cake Mix Recalled for Undeclared Milk Allergen

    Foodstirs is recalling Organic Minute Mug Cake Mix Celebration Confetti 4-packs because individual pouches fail to declare milk as an allergen.

    Product
    Foodstirs Modern Baking; Organic Minute Mug Cake Mix Celebration Confetti - 4 - 2.54 oz. (72g) Pouches per carton -Carton Net Wt. 10.16 oz. (288g) Carton UPC; 816524 02789 Master case UPC: 816524 020796
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0305-2019·2018-11-07

    Philips Brilliance iCT Scanners Recalled for Misleading Calcium Score Reports

    Philips is recalling Brilliance iCT scanners because software errors create confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0339-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0331-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0342-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0322-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0328-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0327-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Instruction Error

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0332-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0346-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0346-2019·2018-11-07

    Faribault Foods Recalls S & W White Beans for Undeclared Sulfites

    Faribault Foods is recalling 2,700 cans of S & W White Beans sold in Oregon and Washington due to undeclared sulfites.

    Product
    S & W White Beans, Net Wt 15 oz (425g), UPC 72273-38807. Distributed by Faribault Foods, 1818 2nd Ave NW, Faribault, MN 55021-3035.
    Category
    Food
    Distribution
    2 states