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.

5426–5450 of 9610

  • ModerateFDA (Devices)·Z-2287-2016·2016-08-03

    LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling

    LeMaitre Vascular is recalling 39 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.

    Product
    AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2265-2016·2016-08-03

    Alere Acceava Mono II Rapid Test Strip Labeling Recall

    Alere San Diego is recalling Acceava Mono II Rapid Test Strips because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2268-2016·2016-08-03

    Alere San Diego Recalls Mono Rapid Test Devices Due to Labeling Error

    Alere San Diego is recalling Henry Schein One Step + Mono Rapid Test Devices because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2270-2016·2016-08-03

    Alere San Diego Recalls Stanbio Rely Mono Rapid Test for Labeling Error

    Alere San Diego is recalling the Stanbio Rely Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2267-2016·2016-08-03

    Alere Clearview MONO Test Recalled for Incorrect Labeling

    Alere San Diego is recalling Clearview MONO tests because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2269-2016·2016-08-03

    Alere Proadvantage Mono Rapid Test Cassette Recalled for Labeling Error

    Alere San Diego, Inc. is recalling Proadvantage Mono Rapid Test Cassettes because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2282-2016·2016-08-03

    Tosoh Bioscience Recalls Progesterone 3 Calibrator Sets Due to Incorrect IFU Lot Number

    Tosoh Bioscience is recalling 41 sets of Progesterone 3 Calibrators because the included Instructions for Use (IFU) listed the incorrect lot number.

    Product
    Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2266-2016·2016-08-03

    Alere Mono Rapid Test Recalled for Incorrect Labeling Information

    Alere San Diego, Inc. is recalling the Cardinal Health Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2271-2016·2016-08-03

    Alere Signify Mono Test Recalled for Incorrect Labeling Information

    Alere San Diego is recalling Signify Mono tests because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1758-2016·2016-07-27

    El Gordo Spices Recalls Dried Shrimp for Missing Sulfite Labeling

    El Gordo Spices is recalling three brands of whole dried shrimp because the labels failed to declare sulfites.

    Product
    Morelos Whole Dried Shrimp Net. Wt. 1 oz.; El Gordo Whole Dried Shrimp Net. Wt. 1 oz.; La Azteca Whole Dried Shrimp Net. Wt. 1 oz. all packaged in cellophane bags
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1764-2016·2016-07-27

    Parker Products Recalls Choco Praline Graham Blend for Undeclared Peanuts

    Parker Products, Inc. is recalling 725 cases of 3015 Choco Praline Graham Blend due to undeclared peanuts. The product was distributed in Ohio and California.

    Product
    3015 Choco Praline Graham Blend Net Weight: 25 lbs/11.34 kgs
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1749-2016·2016-07-27

    Simple Health Recalls Tosi SuperBites for Undeclared Milk and Soy

    Simple Health LLC is recalling Tosi Cappuccino Almond and Crunch Cashew SuperBites due to undeclared milk and soy allergens.

    Product
    Tosi Cappuccino Crunch Cashew SuperBites, 12 bars per pack, Net Wt. 2.6 ounces, UPC 755918046113
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1759-2016·2016-07-27

    El Gordo Spices Recalls Ground Dried Shrimp for Undeclared Sulfites

    El Gordo Spices, LLC is recalling specific brands of ground dried shrimp because the labels failed to declare sulfites.

    Product
    Morelos Ground Dried Shrimp Net. Wt. 3 oz.; 1 oz.; El Gordo Ground Dried Shrimp Net. Wt. 3 oz.; La Azteca Ground Dried Shrimp Net. wt. 3 oz. all packaged in cellophane bags
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1700-2016·2016-07-27

    Herr Foods Recalls Waffle Works Snacks Due to Undeclared Milk Allergen

    Herr Foods is recalling Waffle Works Double Chocolate Waffle Sandwich Snacks because the packaging failed to declare milk (whey powder) as an ingredient.

    Product
    Waffle Works Double Chocolate Waffle Sandwich Snacks Net Wt. 4 OZ.. Distributed By: Herr Foods, Inc., Nottingham, PA 19363. June0616 through February0117
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2253-2016·2016-07-27

    Anspach G1 High Speed Electric Handpiece Recalled for Reversed Interface Graphics

    The Anspach Effort, Inc. is recalling 18 Anspach G1 High Speed Electric Handpiece Air Cooled units because the graphics indicating locked and unlocked positions are reversed.

    Product
    Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1675-2016·2016-07-27

    Botanas Los Mart Velitas Candies Recalled for Undeclared Food Dyes

    Martinez Imports is recalling Botanas Los Mart Velitas Candies because samples contained undeclared artificial colors.

    Product
    Botanas Los Mart Velitas Candies, 10 pieces, Packaged & Distributed by: Martinez Imports, 190 Passaic St. Passaic, NJ, UPC 1 82729302105
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2237-2016·2016-07-27

    Nobel Biocare Dental Implants Recalled for Incorrect Top Label

    Nobel Biocare is recalling 53 Replace Select Tapered dental implants due to incorrect top labels on the packaging. The recall covers units distributed in the US and internationally.

    Product
    Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in or
    Category
    Medical Device
    Distribution
    3 states
  • HighNHTSA·16V547000·2016-07-22

    Forest River Surveyor Recalled for Incorrect Federal Placard Classification

    Forest River is recalling 2016-2017 Surveyor recreational trailers because the Federal Placard incorrectly classifies them as school buses, posing a crash risk due to potential overloading.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1347-2016·2016-07-20

    FUCONPO Capsule Recalled for Marketing Without Approved NDA or ANDA

    Murray International Trading Co. is recalling FUCONPO Capsules because they are marketed as dietary supplements but bear drug claims, making them unapproved drugs.

    Product
    FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1348-2016·2016-07-20

    Murray International Recalls Unapproved Sciatica Pills Marketed as Supplements

    Murray International Trading Co. is recalling 144 bottles of Sciatica Pills because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

    Product
    SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peoples Republic of China, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2016·2016-07-20

    Devicor Mammotome Biopsy System Recalled for Incorrect Needle Packaging

    Devicor Medical Products is recalling Mammotome Revolve biopsy systems because 10-gauge needles were shipped in 8-gauge packages.

    Product
    Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number a
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2151-2016·2016-07-20

    Novarad NovaPACS Diagnostic Viewer Recall for Image Orientation Flipping

    Novarad Corporation is recalling NovaPACS Diagnostic Viewer software versions 7.4, 7.5, 7.6, and 8.0 because images may flip during streaming, potentially displaying incorrect orientation markers.

    Product
    NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1667-2016·2016-07-20

    Silva International Recalls Zesty Nacho Spice Blend for Undeclared Gluten

    Silva International is recalling 10,000 lbs of Zesty Nacho Spice Blend because samples tested positive for gluten, possibly from wheat, which was not disclosed on the label.

    Product
    Zesty Nacho Spice Blend (containing dehydrated chipotle powder) from Silva International packaged in a 50 lb. poly-lined cardboard box.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1590-2016·2016-07-20

    Silva International Recalls Dehydrated Chipotle Powder for Undeclared Gluten

    Silva International is recalling 2,908 lbs of dehydrated chipotle powder because samples tested positive for gluten, possibly from wheat, which was not disclosed on the label.

    Product
    Dehydrated chipotle powder from Silva International packaged in a 50 lb. poly-lined cardboard box.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2202-2016·2016-07-20

    Arrow Femoral Arterial Line Catheterization Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 50 units of Femoral Arterial Line Catheterization Kits due to shipping carton labeling errors.

    Product
    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
    Category
    Medical Device
    Distribution
    2 states