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.

6501–6525 of 21595

  • 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 (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 (Devices)·Z-2872-2020·2020-09-09

    GE Healthcare Recalls OEC 9800 and 9900 C-Arms for Dose Display Issues

    GE Healthcare is recalling 221 OEC 9800 and 9900 C-Arms because field service engineers changed the dose display to DAP, violating FDA regulations requiring AKR/CAK.

    Product
    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, crit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1441-2020·2020-09-09

    Sundial Princess Almaz Spiced Tea Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Princess Almaz Spiced Tea because it is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    SUNDIAL PRINCESS ALMAZ Traditional ETHIOPIAN Organic SPICED TEA; "***Improves circulation***eliminates gas stomach griping & cramps. Relieves acid reflux, coughs, flu, hay fever, allergies, breaks up mucus and fights infection***" packaged in a breathable-type bag within a box.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1499-2020·2020-09-09

    Sundial Herbal Products Recalls Axum Ethiopian Honey Beverage

    Sundial Herbal Products is recalling Axum Ethiopian Honey Beverage because it is misbranded and deemed an unapproved drug based on labeling claims.

    Product
    "AXUM ETHOIPIAN HONEY BEVERAGE***SUNDIAL HERBS***"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1457-2020·2020-09-09

    Sundial Red Water Grass Herbal Product Recalled for Misbranding

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***RED WATER GRASS***1 oz.***USES: FEMALE PROBLEMS, FIBROIDS, INFERTILITY, HIGH BLOOD PRESSURE***" packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1451-2020·2020-09-09

    Sundial Herbal Products Recalls Cerasee Herbal Product for Misbranding

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

    Product
    "SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CERASEE***1 oz.***USES: DIABETES, HYPERTENSION, WORMS, DYSENTERY, MALARIA, BLOOD PURIFIER"; packaged in clear zip-top bags
    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 (Drugs)·D-1555-2020·2020-09-09

    Jaloma Antiseptic Hand Sanitizer Recalled for cGMP Deviations

    Laboratorios Jaloma is recalling 211,875 bottles of Jaloma Antiseptic Hand Sanitizer due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380,
    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-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-1463-2020·2020-09-09

    Sundial Black Wiss Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling Black Wiss 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***BLACK WISS***1 oz.***USES: REGULATES GLANDS, CLEANS JOINTS, INFLAMMATION, SUPPLIES ENERGY***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1445-2020·2020-09-09

    FDA Recalls Sundial Herbal Bitter Kola for Unapproved Drug Claims

    Sundial Herbal Products is recalling Bitter Kola (Arogbo) in New York because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    Bitter Kola (Arogbo); "***a Natural Antibiotic kills all bacteria, virus, Infections and prevent them***it's a good antidote to all poisons, it's used against stomach problem like EBOLA, Colitis, Diarrhea; dysentery etc. It suppresses the Bacteria that causes them***strengthen im
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2924-2020·2020-09-09

    Randox Pancreatic Amylase Reagents Recalled for Performance Failure

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

    Product
    Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2914-2020·2020-09-09

    Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects

    Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect could cause holes and tears at the cuffs.

    Product
    PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1473-2020·2020-09-09

    Sundial Pimento Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling Pimento herbal products under a permanent injunction. The items are misbranded and deemed unapproved drugs due to specific labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PIMENTO***1 oz.***USES: STIMULANT, DIABETES, WORMS, PREVENTS STROKES, REDUCES TOBACCO URGE, WARMS BODY***"; packaged in clear plastic zip-top bags
    Category
    Drug
    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 (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-1364-2020·2020-09-09

    Newman's Own Organic Decaf Coffee Recalled for Containing Non-Organic Beans

    Keurig Dr Pepper is recalling Newman's Own Organic Decaf Ground Coffee because it contains regular non-organic coffee. Consumers should stop using the product.

    Product
    Newman's Own Organics, Newman's Special Decaf Medium Roast, Ground Coffee, 10 oz.
    Category
    Food
    Distribution
    5 states
  • 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-1500-2020·2020-09-09

    Sundial Cassava Meal Recalled as Unapproved Drug

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

    Product
    "SUNDIAL***CASSAVA MEAL***" packaged in brown bags with a clear viewing window
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1476-2020·2020-09-09

    Sundial Purple Sage Herbal Product Recalled for Unapproved Drug Claims

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PURPLE SAGE***1 oz.***USES: DEPRESSION, INSECT BITES, INSOMNIA, RELIEVES CONGESTION***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state