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.

4851–4875 of 9607

  • ModerateFDA (Food)·F-1603-2017·2017-03-22

    Sweets & Desserts Recalls Tres Leches Cakes for Undeclared Food Colors

    Sweets & Desserts, Inc. is recalling Tres Leches cakes in Puerto Rico because they contain undeclared food colors.

    Product
    The Sweet Dessert Corp., Tres Leches (Three Milk Cake), Peso Neto (Net Weight) 3oz and 4 oz., and 4oz (large label) Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1453-2017·2017-03-22

    LeMaitre Vascular Catheter Recalled for Missing Latex Warning Symbol

    LeMaitre Vascular is recalling 46 units of Reddick Scoop Tip Cholangiogram Stiffer Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1465-2017·2017-03-22

    Smiths Medical Recalls Mislabelled Pediatric Tracheostomy Tubes

    Smiths Medical is recalling 142 Bivona TTS Pediatric Tracheostomy Tubes because they were incorrectly labeled for neonatal use instead of pediatric use.

    Product
    Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1462-2017·2017-03-22

    Radiometer ABL90 Flex Analyzer Recalled for Sample Type Labeling Change

    Radiometer America Inc. is recalling ABL90 Flex analyzers because the 'cord blood' sample type was changed to 'cord blood arterial' and 'cord blood venous.'

    Product
    ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1458-2017·2017-03-22

    Terumo Level Sensor II Pads Recalled for Non-Compliant Expiration Date Labeling

    Terumo Cardiovascular Systems Corporation is voluntarily recalling Level Sensor II Pads because the expiration date format may not be recognizable to all users.

    Product
    Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1446-2017·2017-03-22

    LeMaitre Vascular Cholangiogram Catheter Recalled for Missing Latex Symbol

    LeMaitre Vascular is recalling Reddick Scoop Tip Cholangiogram Catheters because the latex warning symbol was missing from the packaging.

    Product
    LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1597-2017·2017-03-22

    Batch International Recalls Chocolate Truffles Due to Allergen Labeling

    Batch International LLC is recalling assorted chocolate truffles because allergens are listed on an internal insert rather than the exterior box.

    Product
    Assorted chocolate truffles, packaged in Kraft colored boxes with the Batch PDX sticker. Boxes contain 5, 8, 12, 18, 24 or 32 pieces with any combination of the following 14 flavors: 1. Vietnamese Iced Coffee 2. Raspberry 3. Spicy Passion 4. Bull Run Bourbon 5. Mint M
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1441-2017·2017-03-22

    RTI Biologics BioSet IC RT Paste Recalled for Incorrect Instructions

    RTI Surgical is recalling 24 units of BioSet IC RT Paste due to incorrect instructions for use. The product was distributed in Colombia.

    Product
    RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1439-2017·2017-03-22

    Smiths Medical Recalls CADD Solis VIP Pumps for Mistranslated Message

    Smiths Medical ASD, Inc. is recalling 20 CADD Solis VIP Ambulatory Infusion Pumps sold in Finland due to a mistranslated error message. The pump's function is unchanged, and no patient injury can occur.

    Product
    CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0603-2017·2017-03-22

    Pharmedium Recalls Buffered Lidocaine Syringes Due to Labeling Error

    Pharmedium Services, LLC is recalling 3,879 syringes of Buffered Lidocaine because the outer packaging is incorrectly labeled as 1% instead of 0.9%.

    Product
    Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1454-2017·2017-03-22

    Bencox Mirabo PE Liner Recalled for Incorrect Instruction Manual

    Corentec Co., Ltd. is recalling five units of Bencox Mirabo PE Liners distributed in Pennsylvania because they may contain Chinese instructions instead of US instructions.

    Product
    Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0521-2017·2017-03-22

    PreviDent Toothpaste Recalled for Incorrect Rear Panel Labeling

    Colgate is recalling 14,656 bottles of PreviDent 5000 toothpaste because the rear panel is incorrectly labeled with text from a different product.

    Product
    PREVIDENT — PREVIDENT (SODIUM FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateNHTSA·17V197000·2017-03-21

    Fleetwood and Holiday Rambler RVs Recalled for Incorrect Tire Placards

    REV Recreation Group is recalling 2017 Fleetwood Bounder and Holiday Rambler Vacationer RVs because Federal Placards list the wrong tire size.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER BOUNDER, VACATIONER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1566-2017·2017-03-15

    Private Selection Salted Caramel Chocolate Almond Pie Recalled for Allergen Mislabeling

    Legendary Baking is recalling Private Selection Salted Caramel Chocolate Almond Pie because the label failed to list eggs and almonds as ingredients.

    Product
    Private Selection, Salted Caramel Chocolate Almond Pie, NET WT 34 OZ ( 2 LB 2 OZ) 963g, UPC 1111054021. Container: In a labeled pie dome and base. Pies are distributed frozen. Some stores sell refrigerated and some sell frozen.
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-1404-2017·2017-03-15

    See Clear Company Recalls Color Contact Lenses for Sterility and Labeling Issues

    The See Clear Company is recalling 119,829 units of color contact lenses because they may not be sterile and may have incorrect lot numbers or expiry dates.

    Product
    Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1575-2017·2017-03-15

    Robert Rothschild Farm Recalls Gift Sets with Chocolate Pretzel Dippers

    Robert Rothschild Farm LLC is recalling Gift Sets with Chocolate Pretzel Dippers because the product is not labeled with an ingredient statement, failing to declare the allergens soy and wheat.

    Product
    Gift Sets with Chocolate Pretzel Dippers
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1569-2017·2017-03-15

    Hormel Recalls Great Shake Fortified Nutrition Drinks for Undeclared Milk

    Hormel Foods is recalling Great Shake and Great Shake Plus fortified nutrition drinks due to the presence of undeclared milk.

    Product
    Great Shake Fortified Nutrition, Soy Formula, Strawberry Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen.
    Category
    Food
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-1403-2017·2017-03-15

    Merge Cardio software recalled for incorrect measurement units in reports

    Merge Healthcare is recalling Merge Cardio software versions 9.0 and 10.0 because measurements from images or US carts do not transfer to reports in the correct unit of measure.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1407-2017·2017-03-15

    MicroAire K-Wires Recalled for Incorrect Product Labeling

    MicroAire Surgical Instruments is recalling 362 K-Wires due to mislabeling that incorrectly identified them as dual trocar instead of single trocar.

    Product
    MicroAire K-Wires
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1426-2017·2017-03-15

    Merge Unity PACS Software Recalled for Missing Demographic Data

    Merge Healthcare is recalling Unity PACS software version 11.0 because reports faxed to referring physicians were missing demographic header information.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0510-2017·2017-03-15

    LEO Pharma Recalls Calcipotriene Cream Due to Labeling Errors

    LEO Pharma is recalling 272,062 tubes of Calcipotriene Cream because the label omitted a required excipient and a warning about contact dermatitis.

    Product
    CALCIPOTRIENE — CALCIPOTRIENE (CALCIPOTRIENE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1416-2017·2017-03-15

    US Endoscopy Recalls Roth Net Polyp Retrieval Due to Date Mismatch

    US Endoscopy Group Inc is recalling Roth Net Polyp Retrieval devices because the expiration date on the outer carton is shorter than the date on the inner package.

    Product
    Roth Net Polyp Retrieval
    Category
    Medical Device
    Distribution
    15 states