The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

6451–6475 of 21595

  • ModerateFDA (Devices)·Z-2937-2020·2020-09-16

    Hager & Meisinger Recalls Dental Burs Due to Labeling Discrepancy

    Hager & Meisinger is recalling 144 units of SINGLES Carbide dental burs because the US dates on the package label do not match the bar code display.

    Product
    SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2940-2020·2020-09-16

    Medcomp Titan HD Catheter Kits Recalled for Incorrect Valve Size

    Medical Components, Inc. is recalling 132 Medcomp Titan HD catheter kits because they were packaged with a 15F valve instead of the correct 16F valve.

    Product
    Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-1562-2020·2020-09-16

    Edge Pharma Recalls Vancomycin IV Bags Due to Labeling Error

    Edge Pharma, LLC is recalling Vancomycin HCL 1.5 mg IV bags distributed in Wisconsin due to a label error regarding the declared strength.

    Product
    Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0013-2021·2020-09-16

    Teva Recalls Cephalexin Oral Suspension Due to CGMP Deviations

    Teva Pharmaceuticals is recalling Cephalexin for Oral Suspension because current Good Manufacturing Practice deviations may cause active ingredient levels to fall outside specification limits.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2933-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 13 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1456-2020·2020-09-09

    Sundial Mango Leaf Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Mango Leaf herbal products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO LEAF***1 oz.***USES: KIDNEY STONES, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1479-2020·2020-09-09

    Sundial White Jointa Herbal Product Recalled for Misbranding

    Sundial Herbal Products is recalling White Jointa herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE JOINTA***1 oz.***USES: NERVES, COLD, ASTHMA, BRONCHITIS, MUCOUS FEVER MENSTRUAL PROBLEMS***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2928-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 2,444 StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1461-2020·2020-09-09

    Sundial Herbal Products Recalls Dog Blood Herbal Product for Misbranding

    Sundial Herbal Products is recalling Dog Blood herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DOG BLOOD***1 oz.***USES: FIBROIDS, CYST, CLEANS WOMB, WOMAN IMBALANCE, PREVENT MISCARRIAGE***"; packaged in clear plastic zip-top bag
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1501-2020·2020-09-09

    Sundial Herbal Products Recalls Cocoa Balls for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Cocoa Balls because the product is misbranded and deemed an unapproved drug based on labeling claims.

    Product
    "SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2932-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 2,197 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an elect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2923-2020·2020-09-09

    Randox Laboratories Recalls Amylase Reagents Due to Performance Failures

    Randox Laboratories is recalling specific batches of Amylase reagents because they failed to meet performance claims prior to their September 2020 expiry date.

    Product
    Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1560-2020·2020-09-09

    Bersih Hand Sanitizer Gel Recalled for cGMP Deviations

    Soluciones Cosmeticas, SA de CV is voluntarily recalling Bersih Hand Sanitizer Gel due to cGMP deviations. The product was distributed in the United States.

    Product
    Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1454-2020·2020-09-09

    Sundial Bitter Wood Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Bitter Wood herbal products under a court order because the labels make unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BITTER WOOD***2 oz.***USES: EXPELS WORMS IN THE WEST INTESTINES, DESTROYS PARASITES, LEUKEMIA, DESTROY APPETITE FOR ALCOHOL***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1462-2020·2020-09-09

    Sundial Black Sage Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Black Sage herbal products under a permanent injunction because the labeling makes unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLACK SAGE***1 oz.***USES: ALZHEIMER'S DISEASE, GINGIVITIS, MENOPAUSE, APPLY DIRECTLY TO SKIN FOR COLD SORES, ASTHMA***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1440-2020·2020-09-09

    FDA Recalls Sundial Ethiopian Tenadam Herb for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Ethiopian Tenadam Herb because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "***Strengthens the Vein & Capillaries***lowers high Blood pressure, regulate Heartbeat.***heals Stomach ulcers***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1488-2020·2020-09-09

    Sundial Wood and Root Tonic Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling Wood and Root Tonic under a permanent injunction because the product is misbranded and deemed an unapproved drug.

    Product
    "Sundial***Traditional Jamaican***ORGANIC***Original Maroon Recipe***WOOD AND ROOT TONIC***used for centuries in Jamaica as a household remedy, to cleanse the body and the blood of mucus, and toxic waste.***used by the Carib Indians of Central America to Protect them against epid
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2930-2020·2020-09-09

    Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component

    Stimwave Technologies is recalling 1,424 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not referenced in product labeling.

    Product
    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical cu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1489-2020·2020-09-09

    Sundial Herbal Products Recalls Koromantee Colonic Cleaner as Unapproved Drug

    Sundial Herbal Products is recalling Koromantee Colonic & Intestinal Cleaner because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    "SUNDIAL***KOROMANTEE***Colonic & Intestinal Cleaner***used by the descendants of the Koromantee people in Jamaica to help cleanse and strengthen the bowels, stomach, intestines, and colonic areas of the body.***" packaged in 16oz glass bottles
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1468-2020·2020-09-09

    Sundial Fever Grass Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Fever Grass herbal products under a court order because the labels make unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***FEVER GRASS***1oz.***USES: FEVER, COLD, MALARIA, FLU, COUGH, PNEUMONIA, HEADACHE, NERVES, STOMACH & BOWEL***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1458-2020·2020-09-09

    Sundial Herbal Products Recalls Misbranded Sarsaparilla Herbal Product

    Sundial Herbal Products is recalling Sarsaparilla herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***SARSAPARILLA***2 oz.***USES: BLOOD CLEANSER, BALANCES HORMONES, PRODUCTIVE ORGANS, SYPHILIS, ECZEMA, PSORIASIS***"; packaged in clear plastic zip-top bags.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1455-2020·2020-09-09

    Sundial Devil Horsewhip Herbal Product Recalled for Misbranding

    Sundial Herbal Products is recalling Devil Horsewhip herbal products under a court order because the items are misbranded and considered unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DEVIL HORSEWHIP***1 oz.***USES: COUGH, COLD, CHEST PAIN,***FEVER, VENEREAL DISEASE***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1465-2020·2020-09-09

    Sundial African Fever Bush Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling African Fever Bush under a permanent injunction because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***African Fever Bush***1oz***USES: FEVER, WORMS IN CHILDREN
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1449-2020·2020-09-09

    Sundial Mahogany Bark Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Mahogany Bark herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    SUNDIAL Traditional Herbal Products***Mahogany Bark ***2 oz.***USES: BODY WEAKNESSES, MALE REPRODUCTIVE ORGANS, INFERTILITY***" packaged in zip-top plastic bag
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1480-2020·2020-09-09

    Sundial White Sage Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling White Sage herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE SAGE***2 oz.***USES: EXCESS SWEATING, FEMALE HORMONE, SINUS INFECTION, INDIGESTION, KILLS BACTERIA***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state