The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

526–550 of 2766

  • LowFDA (Devices)·Z-1908-2020·2020-05-13

    Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 22,439 units of Gentell Honey Hydrogel 4"x4" Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1849-2020·2020-05-13

    Epimed RF Injector Cannula Recalled for Incorrect Expiration Date

    Epimed International is recalling 1,374 units of RF Injector Cannulas due to incorrect expiration dates on the packaging.

    Product
    R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0926-2020·2020-05-06

    Calci-Max Dietary Supplement Recalled for Zinc Content Deficiency

    Alfa Vitamins Laboratories is recalling Calci-Max dietary supplements because FDA testing found the product contained 0.0% of the labeled zinc content.

    Product
    CALCI-MAX Dietary Supplement, 60 capsules, Manufactured for: DOMEL
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-1256-2020·2020-05-06

    Dr. Reddy's Recalls Esomeprazole Magnesium Capsules Due to Discoloration

    Dr. Reddy's Laboratories is recalling 1,752 bottles of Esomeprazole Magnesium 40 mg capsules because the product contains brown pellets.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1834-2020·2020-05-06

    Ortho VITROS TT4 Reagent Pack Recalled for Calibration Failures

    Ortho Clinical Diagnostics is recalling VITROS TT4 Reagent Packs due to increased unsuccessful calibrations. The recall affects 3,181 units distributed in the US and 23 other countries.

    Product
    VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0930-2020·2020-05-06

    Golden Nutrition Recalls Biotin Supplement Due to Low Content

    Golden Nutrition is recalling Biotin 1000mcg tablets because FDA testing found the biotin content was only 0.8% of the label claim.

    Product
    Biotin 1000mcg, Dietary Supplement, 30 Tablets, Manufactured by: Golden Nutrition
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-1694-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 437 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1695-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 110 Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0923-2020·2020-04-22

    CT Health Solutions Recalls Lycopene Dietary Supplement Due to Low Potency

    CT Health Solutions is recalling 1,500 bottles of We Like Vitamins Lycopene 50 mg dietary supplement because the product was found to have low potency.

    Product
    We Like Vitamins, Lycopene 50 mg, Dietary Supplement, 200 Capsules
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-1713-2020·2020-04-22

    CooperSurgical Recalls Wallace Catheters Due to Expiration Date Error

    CooperSurgical is recalling Wallace Artificial Insemination Catheters because the expiration date was marked as 5 years instead of 3 years.

    Product
    Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-0872-2020·2020-04-08

    Nature's Blend Folic Acid Recalled for Labeling Error

    National Vitamin Company is recalling Nature's Blend Folic Acid 1000 mcg bottles due to a front panel label error stating 1000 mg instead of 1000 mcg.

    Product
    Nature's Blend Folic Acid 1000 mcg Dietary Supplement, 1000-count bottle, Product Number: 1280, UPC 0-79854-51280-9
    Category
    Food
    Distribution
    18 states
  • LowFDA (Devices)·Z-1625-2020·2020-04-08

    Gentell Hydrogel Ag Saturated Gauze Recalled for FDA Registration Deficiency

    Gentell, Inc. is recalling 6,433 units of Gentell Hydrogel Ag Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1258-2020·2020-04-08

    Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure

    Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because retained sample testing showed total impurities exceeded the allowed limit.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1626-2020·2020-04-08

    Gentell Hydrogel Ag Wound Dressing Recalled for Registration Issues

    Gentell, Inc. is recalling Gentell Hydrogel Ag wound dressings because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, fir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1565-2020·2020-04-01

    Cook Inc. Recalls Pericardiocentesis Sets Due to Incorrect Expiration Dates

    Cook Inc. is recalling 25 Pericardiocentesis Sets because the printed expiration dates are incorrect. The products were distributed to seven US states and Canada.

    Product
    Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-1049-2020·2020-04-01

    FDA Recalls Colostat Homeopathic Remedy Due to Incorrect Labeling

    Grato Holdings, Inc. is recalling 659 bottles of Colostat homeopathic remedy because the indications on the product label are incorrect.

    Product
    COLOSTAT — COLOSTAT (RHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICA)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1029-2020·2020-03-25

    Strides Pharma Recalls Potassium Chloride Tablets Due to Oversized Size

    Strides Pharma Science Limited is recalling specific lots of Potassium Chloride Extended-Release Tablets because oversized tablets were found.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1055-2020·2020-03-18

    Lupin Recalls Bekyree Tablets Due to Content Uniformity Failures

    Lupin Pharmaceuticals is recalling specific lots of Bekyree oral contraceptives because they failed content and blend uniformity tests.

    Product
    Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1470-2020·2020-03-18

    Integra NeuraGen Nerve Guide Recalled for Quality Control Error

    Integra LifeSciences is recalling 55 units of NeuraGen Nerve Guides because nonconforming product was mistakenly released for commercial use.

    Product
    NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1441-2020·2020-03-11

    Advanced Bionics Recalls SoundWave Professional Suite Software 3.2

    Advanced Bionics is recalling SoundWave Professional Suite Software 3.2 because the installation process fails when using the supplied USB drive, though current software versions remain functional.

    Product
    SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with A
    Category
    Medical Device
    Distribution
    Distributed nationwide