The Recall Desk

Hazard

Mis Labeling recalls

9,611 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,611
Critical
161
Severe
589
Most recent
2026-09-24

Of the 9,611 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 589 (6%) are Severe.

Which agencies issued them

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.

8426–8450 of 9611

  • ModerateFDA (Devices)·Z-2258-2013·2013-09-25

    Spine Smith VisuALIF PEEK Block Recall Due to Potential Sizing Mislabeling

    Spine Smith Holdings is recalling 32 VisuALIF PEEK blocks because they may be marked as Medium when they are actually Small.

    Product
    VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2259-2013·2013-09-25

    Kerr Recalls NX3 Try-In Gel Due to Material Mismatch

    Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel because some syringes contain a different material than the labeled shade.

    Product
    NX3 Try-In Gel. The product is used as a tooth shade resin material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2254-2013·2013-09-25

    Access Scientific Recalls Mislabeled POWERWAND Safety Introducer Catheters

    Access Scientific is recalling 160 units of the POWERWAND Safety Introducer with Extended Dwell Catheter because the product is mislabeled.

    Product
    POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1056-2013·2013-09-25

    Vicks NyQuil Liquid Recalled for Incorrect Undeclared Excipients Labeling

    Procter & Gamble is recalling Vicks NyQuil Cold and Flu Nighttime Relief Liquid Twin Packs because the outer wrap incorrectly identifies color additives.

    Product
    Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5mg), 12 fl oz (354 ml) bottles, Distributed by Procter & Gamble, Cincinnati, OH 45202, NDC 37000-807-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1904-2013·2013-09-25

    Novartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling specific lots of Benefiber Orange Creme Chewables because the lot number and expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Benefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewable tablet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1905-2013·2013-09-25

    Novartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Benefiber fiber supplement bottles because the lot number and expiration date may be illegible on the outer packaging.

    Product
    Benefiber, Fiber Supplement, 72ct and 114 caplet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1903-2013·2013-09-25

    Novartis Recalls Benefiber Wild Berry Chewables Due to Illegible Labeling

    Novartis Consumer Health is recalling specific lots of Benefiber Wild Berry Chewables because the lot number and expiration date may be illegible on the outer packaging.

    Product
    Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2255-2013·2013-09-25

    King LT-D Oropharyngeal Airways Recalled for Packaging Labeling Error

    King Systems Corp. is recalling King LT-D Oropharyngeal Airways because size 5 units were packaged in pouches labeled as size 2.5.

    Product
    King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach conten
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Food)·F-1906-2013·2013-09-25

    Novartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling 419,040 units of Benefiber chewable tablets because the lot number and expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1907-2013·2013-09-25

    Novartis Recalls Benefibre Orange Creme Chewables Due to Illegible Labeling

    Novartis Consumer Health is recalling specific lots of Benefibre Orange Creme Chewables because the lot number and expiration date may be illegible on the packaging.

    Product
    Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: Novartis Consumer Health Canada Inc, Mississauga, ON.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2126-2013·2013-09-18

    Siemens Microscan Plus Negative Breakpoint Combo 4 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.

    Product
    Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2124-2013·2013-09-18

    Siemens Microscan Plus Negative Combo 3 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-nega
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2125-2013·2013-09-18

    Siemens Microscan plus Negative Urine Combo 4 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Urine Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.

    Product
    Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2123-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Urine Combo 5 Recall

    Siemens is recalling Microscan Synergies Plus Negative Urine Combo 5 panels due to confirmed false susceptibility results for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2120-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Combo 2 Recall for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Combo 2 panels due to confirmed false susceptible and intermediate misreads for Imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2013·2013-09-18

    Siemens Microscan rapID/S panels recalled for false susceptibility results

    Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptibility and intermediate misreads for imipenem and meropenum.

    Product
    Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Urine Combo 1 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 1 panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2013·2013-09-18

    Siemens Microscan rapID/S panels recalled for false susceptibility results

    Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Urine Combo 2 Recall

    Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 2 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2013·2013-09-18

    Siemens MicroscanrapID/S panels recalled for antimicrobial misreads

    Siemens Healthcare Diagnostics is recalling MicroscanrapID/S panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.

    Product
    MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2013·2013-09-18

    Roche Recalls cobas 4800 HPV Test Kits Due to Formulation Error

    Roche Molecular Systems is recalling specific lots of cobas 4800 HPV test kits because a formulation error was identified during the manufacture of the Master Mix reagent.

    Product
    KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Hum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1037-2013·2013-09-18

    Qualitest Recalls Effervescent Potassium Chloride Tablets Due to Labeling Error

    Qualitest Pharmaceuticals is recalling 1,680 boxes of effervescent potassium chloride tablets because they may be mislabeled as a different potassium product.

    Product
    EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION, USP, FRUIT PUNCH FLAVOR, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1036-2013·2013-09-18

    Qualitest Recalls K Effervescent Tablets Due to Labeling Mix-up

    Qualitest Pharmaceuticals is recalling 1,680 boxes of K Effervescent Tablets because they may be mislabeled as Potassium/Chloride Tablets.

    Product
    K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook,
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2162-2013·2013-09-18

    Medical Indicators Recalls Tempa DOT Single-Use Clinical Thermometers

    Medical Indicators, Inc. is recalling Tempa DOT single-use clinical thermometers due to potential mislabeling. The recall affects 111,800 boxes distributed nationwide.

    Product
    Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medica
    Category
    Medical Device
    Distribution
    Distributed nationwide