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.

1776–1800 of 9607

  • ModerateFDA (Devices)·Z-0080-2021·2020-10-14

    Bard Conquest PTA Balloon Catheter Recalled for Incorrect Balloon Size

    Bard Peripheral Vascular Inc is recalling 281 units of the Conquest PTA Balloon Dilation Catheter because some units contain a 5mm balloon instead of the labeled 6mm size.

    Product
    Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3022-2020·2020-10-07

    Encore Medical Recalls Humeral Socket Inserts Due to Size Mismatch

    Encore Medical is recalling 37 humeral socket inserts because the size etched on the product may differ from the size on the patient sticker label.

    Product
    RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-3021-2020·2020-10-07

    Encore Medical Recalls Mislabeled Humeral Socket Inserts

    Encore Medical is recalling 15 units of RSP Standard Humeral Socket Inserts due to size labeling discrepancies that could lead to incorrect implantation.

    Product
    RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-3036-2020·2020-10-07

    Ameditech Recalls ImmuTest Drugs of Abuse Cups for Performance Failures

    Ameditech is recalling ImmuTest Drugs of Abuse Cups because they failed to consistently detect all compounds at labeled levels.

    Product
    ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3041-2020·2020-10-07

    Ameditech Recalls Oratect III Oral Fluid Drug Screen Devices

    Ameditech Inc is voluntarily recalling 1,325 units of Oratect III Oral Fluid Drug Screen Devices due to a Class II safety concern.

    Product
    Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1626-2020·2020-10-07

    Legacy Pharmaceutical Recalls Metformin Tablets Due to Foreign Imprint

    Legacy Pharmaceutical Packaging LLC is recalling 111,948 bottles of Metformin Hydrochloride 1000 mg tablets because tablets with different imprints were found in the bottles.

    Product
    Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-3035-2020·2020-10-07

    Ameditech Recalls One Step + DOA Cup Due to Performance Failures

    Ameditech is recalling 31,800 units of the Henry Schein One Step + DOA Cup because the immunoassay enzymes failed performance tests, resulting in inconsistent detection of compounds.

    Product
    Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3044-2020·2020-10-07

    Ameditech Recalls TDDA Drugs of Abuse Cups Due to Performance Failures

    Ameditech Inc is recalling TDDA Drugs of Abuse Cups because the immunoassay enzymes failed to consistently detect all compounds at labeled levels.

    Product
    TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3031-2020·2020-10-07

    Ameditech Recalls Alere iCup Drug Detection Cups Due to Performance Failures

    Ameditech Inc is recalling Alere iCup Drug Detection cups because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.

    Product
    Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0004-2021·2020-10-07

    Rite Aid Nicotine Gum Recalled for Incorrect Package Insert

    P & L Developments is recalling 4,752 cartons of Rite Aid 2 mg nicotine gum because the package insert is for the Canadian market and not the approved US labeling.

    Product
    Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1586-2020·2020-09-30

    Leafree Hand Sanitizer Recalled for Lacking FDA Approval

    Corgiomed LLC is recalling Leafree Instant Hand Sanitizer because it was marketed without FDA approval and labeled as edible alcohol.

    Product
    Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, Mc
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-3012-2020·2020-09-30

    Irvine Biomedical Recalls Steerable Diagnostic Catheters Due to Labeling Error

    Irvine Biomedical is recalling 40 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and lot numbers, potentially causing procedure delays.

    Product
    Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2983-2020·2020-09-30

    Beckman Coulter Recalls DxA 5000 Automated Sample Handling Systems

    Beckman Coulter is recalling 32 DxA 5000 automated sample handling systems because the instructions for use may be confusing regarding the re-use of sample IDs, leading to undetected barcode re-use.

    Product
    DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents samp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2982-2020·2020-09-30

    Bio-Rad Recalls BioPlex 2200 Syphilis Assay Due to Increased Reactivity

    Bio-Rad is recalling BioPlex 2200 Syphilis Total & RPR kits because of increased RPR reactivity levels in the kit material.

    Product
    BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-trepo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3011-2020·2020-09-30

    Irvine Biomedical Recalls Steerable Diagnostic Catheters Due to Labeling Error

    Irvine Biomedical is recalling 15 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and batch numbers.

    Product
    Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1580-2020·2020-09-23

    Scent Theory Hand Sanitizer Recalled for Methanol Contamination

    Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer is being recalled because it contained methanol and fell below the labeled ethanol content.

    Product
    scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distributed by Scent Theory Products, LLC New York, NY 10018. Made in Mexico, UPC 8 40038 21434 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1581-2020·2020-09-23

    Born Basic Hand Sanitizer Recalled for Methanol Contamination

    The FDA is recalling Born Basic Anti-Bac Hand Sanitizer because it contained methanol and had lower ethanol levels than labeled. The recall includes other products from the same manufacturing facility.

    Product
    BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·20V577000·2020-09-23

    2021 Airstream Basecamp Trailers Recalled for Incorrect Tire Placard Information

    Airstream is recalling certain 2021 Basecamp 16 trailers because the tire placard displays incorrect tire size and inflation pressure. If tires are inflated per the incorrect label, they could become dangerously underinflated, increasing crash risk.

    Product
    AIRSTREAM — AIRSTREAM BASECAMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1509-2020·2020-09-23

    Fresco Foods Recalls Jackfruit Bowls Due to Undeclared Fish Allergen

    Fresco Foods is recalling Ancient Grain Jackfruit Bowls because the packaging failed to disclose the presence of anchovies, a fish allergen.

    Product
    Ancient Grain Jackfruit Bowl with Chickpeas & Edamame in a Thai Coconut Sauce, Eat Fresco, Keep Refrigerated, NET WT 14oz (397gr), Cook Thoroughly
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2966-2020·2020-09-23

    Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples

    Randox Laboratories is recalling 143 kits of the AM1054 Ammonia reagent because it shows a positive bias of up to 140 µmol/l on patient samples.

    Product
    AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-1522-2020·2020-09-23

    Herr's Potato Chips Recalled for Undeclared Allergens and Ingredients

    Herr Foods Inc is recalling GameDay Tailgate Tacos Flavored Potato Chips due to undeclared black bean powder, jalapeno pepper powder, paprika, and other ingredients.

    Product
    Herr s GameDay Tailgate Tacos Flavored Potato Chips 6.5 oz. packaged in a flexible metalized bag. UPC Code: 7260006434
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2981-2020·2020-09-23

    Roche Recalls Anti-TPO Assay Kits Due to Updated Interference Claim

    Roche Diagnostics is recalling 11,870 Elecsys Anti-TPO Assay kits because internal studies found the radio frequency interference claim no longer met for specific cobas e analyzers.

    Product
    Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2971-2020·2020-09-23

    Cook Medical Recalls Universa Soft Ureteral Stent Sets Due to Packaging Error

    Cook Inc. is recalling 20 units of Universa Soft Ureteral Stent Sets because they were incorrectly placed in boxes labeled for the Firm version.

    Product
    Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1508-2020·2020-09-23

    Coolhaus Ice Cream Sandwich Recalled for Undeclared Soy Lecithin

    Coolhaus is recalling specific lots of 'That Dough Though' ice cream sandwiches because the package label does not declare soy lecithin.

    Product
    Coolhaus Awesome Ice Cream -That Dough Though Ice Cream Sandwich; Chocolate chip cookies, cookie dough batter with gobs of cookie dough. Keep Frozen Contains: Milk, Wheat, Eggs 5.8 oz . serve package - polypropylene film wrapper. UPC: 8 51916 00349 0 Coolhaus, Culver
    Category
    Food
    Distribution
    15 states