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.

11751–11775 of 21617

  • ModerateFDA (Food)·F-0118-2018·2017-11-15

    Melissa's Original Polenta Recalled for Unapproved Ink Contact

    San Gennaro Foods is recalling Melissa's Original Polenta because date coding ink was printed directly on the food contact surface, allowing the unapproved ink to contact the product.

    Product
    Original Polenta, Melissa's brand, Shelf stable, 12/16 oz package UPC# 0-45255-11847-6 Ingredients: Water, Organic Cornmeal, Salt, Yeast Extract, Organic Granulated Onion, Organic Granulated Garlic, Organic Celery Seed, Tartaric Acid, Ascorbic Acid, Beta Carotene
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0079-2018·2017-11-15

    Boston Scientific Recalls Four VIGILANT X4 CRT-D Devices for Firmware Error

    Boston Scientific is recalling four VIGILANT X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1)
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0084-2018·2017-11-15

    BD Vacutainer Blood Collection Tubes Recalled for Incorrect Labeling

    Becton Dickinson is recalling 90,000 blood collection tubes due to incorrect labeling at the case and shelf pack level.

    Product
    BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No. 364960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0082-2018·2017-11-15

    Invivo Recalls Xper Flex Cardio PhysioMonitoring Systems Due to Communication Errors

    Invivo Corporation is recalling 529 Xper Flex Cardio PhysioMonitoring systems because of intermittent communication issues between the host system and the device.

    Product
    Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be profe
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0066-2018·2017-11-15

    Encore Medical Recalls Cobalt Bone Cement Due to Packaging Seal Loss

    Encore Medical, Lp is recalling 1,815 units of Cobalt MV with Gentamicin bone cement because the sterile Tyvek packaging seal was lost.

    Product
    Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·122-2017·2017-11-15

    Texas Natural Meats Recalls Frozen Beef Tongue Due to Specified Risk Materials

    Texas Natural Meats is recalling approximately 116 pounds of frozen beef tongue products that may be contaminated with specified risk materials (SRMs).

    Product
    Texas Natural Meats — Texas Natural Meats Recalls Beef Products Due To Possible Specified Risk Materials Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0071-2018·2017-11-15

    Ace Surgical Recalls Mislabeled Succinylcholine Vials Due to Expiration Date Error

    Ace Surgical Supply Co. is recalling 25 vials of Succinylcholine 20 mg/mL due to an incorrect expiration date on the outer poly bag labeling.

    Product
    Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0077-2018·2017-11-15

    Boston Scientific Recalls Five Resonate EL ICD VR Devices for Firmware Error

    Boston Scientific is recalling five Resonate EL ICD VR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    RESONATE EL ICD VR, Model D432, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0121-2018·2017-11-15

    San Gennaro Foods Recalls Polenta Due to Unapproved Ink Contact

    San Gennaro Foods is recalling multiple brands of organic polenta because date coding ink was printed directly on the food contact surface of the packaging.

    Product
    Basil Garlic Organic Polenta, Ancient Harvest brand, Pre-cooked ready-to-heat, 12/18 oz packages UPC# 6-59201-10203-9 Traditional Organic Polenta, Trader Joe's brand, Pre-cooked ready-to-heat and serve, 12/18oz package UPC# 0079-7177 Basil Garlic Organic Polenta, Frieda's
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Food)·F-0352-2018·2017-11-15

    Harmless Harvest Recalls Probiotic Drinks Due to Spoilage

    Harmless Harvest is recalling four varieties of probiotic drinks because testing identified Candida lusitaniae as the cause of premature spoilage.

    Product
    Harmless Coconut Probiotics Mangos & Acerolas; Coconut Cultured Beverage; UPC 859078-002719 ; 11 lf. oz. HDPE Bottle; Keep refrigerated Ingredients: Organic Coconut Water, Water, Organic Coconut Meat, Organic Cane Sugar, Organic Mangos, Organic Acerolsas, live and active
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0080-2018·2017-11-15

    Boston Scientific Recalls Four Momentum X4 CRT-D Devices for Firmware Error

    Boston Scientific is recalling four Momentum X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

    Product
    MOMENTUM X4 CRT-D, Model G138, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0129-2018·2017-11-15

    San Gennaro Sundried Tomato Polenta Recalled for Unapproved Packaging Ink

    San Gennaro Foods is recalling Sundried Tomato Polenta because date coding ink was printed directly on the food contact surface of the packaging.

    Product
    Sundried Tomato Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/24 oz packages, UPC# 7-62676-12401-4 Sundried Tomato Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/18 oz packages, UPC# 7-62676-15001-3 Sundried Tomato Polenta, San Gennaro C
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Food)·F-0123-2018·2017-11-15

    San Gennaro Foods Recalls Sundried Tomato Polenta Due to Ink Contact

    San Gennaro Foods is recalling sundried tomato polenta products because non-food-grade ink was printed directly on the packaging, allowing it to contact the food.

    Product
    Sundried Tomato Organic Polenta, Ancient Harvest brand, Pre-cooked ready-to-heat, 12/18 oz packages, UPC# 6-59201-10202-2 Sundried Tomato Organic Polenta, Frieda's brand, Pre-cooked just heat & serve, 12/16 oz packages, UPC# 0-37842-04156-4 Sundried Tomato Polenta, Zerto
    Category
    Food
    Distribution
    18 states
  • ModerateNHTSA·17V711000·2017-11-14

    Forest River Recalls 2018 Prime Time Fury Trailers for Incorrect Placards

    Forest River is recalling 2018 Prime Time Fury recreational trailers because the Federal Placard lists incorrect tire and rim sizes, which could lead to the installation of wrong replacement tires.

    Product
    PRIME TIME — PRIME TIME FURY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0080-2018·2017-11-08

    Wegmans Half Cheese Danish Twist Recalled for Undeclared Ingredients

    Wegmans is recalling Half Cheese Danish Twists because they contain undeclared FD&C Yellow 5, Yellow 6, Potassium Sorbate, and High Fructose Corn Syrup.

    Product
    038973 - Wegmans Half Cheese Danish Twist, 6 oz. UPC: 0 77890 38973 7
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0057-2018·2017-11-08

    Precision Dose Recalls Subpotent Carbamazepine Oral Suspension Unit Dose Cups

    Precision Dose Inc. is recalling Carbamazepine Oral Suspension USP unit dose cups because they tested below the required potency specifications.

    Product
    Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0055-2018·2017-11-08

    AvKARE Recalls Duloxetine Capsules Due to Slightly Elevated Phthalic Acid

    AvKARE is recalling 274 cartons of Duloxetine Delayed-release Capsules 20 mg due to slightly elevated levels of phthalic acid.

    Product
    Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0083-2018·2017-11-08

    Wegmans Round Danish Recalled for Undeclared Ingredients

    Wegmans is recalling Round Danish products due to undeclared ingredients including FD&C Yellow 5 and Yellow 6, Potassium Sorbate, and High Fructose Corn Syrup.

    Product
    034208 Wegmans Round Danish, 6 pack. UPC: 0 77890 34208 4.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0069-2018·2017-11-08

    Teva Recalls Dutasteride and Tamsulosin HCl Capsules for Dissolution Failures

    Teva Pharmaceuticals is recalling specific lots of Dutasteride and Tamsulosin HCl capsules because they failed dissolution specifications.

    Product
    Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippan
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0082-2018·2017-11-08

    Wegmans Puff Fruit Dumplings Recalled for Undeclared Ingredients

    Wegmans is recalling Puff Fruit Dumplings because they contain undeclared FD&C Yellow 5, FD&C Yellow 6, Potassium Sorbate, and High Fructose Corn Syrup.

    Product
    033710 - Wegmans Puff Fruit Dumplings, 2 Pack, 6 oz. UPC: 0 77890 33710 3
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0081-2018·2017-11-08

    Wegmans Turnovers Recalled for Undeclared Ingredients and Additives

    Wegmans is recalling assorted turnovers due to undeclared Yellow 5, Yellow 6, Potassium Sorbate, and High Fructose Corn Syrup.

    Product
    085194 - Wegmans Turnovers, Assorted, 2 Pack, 9 oz. UPC: 0 77890 85194 4
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0084-2018·2017-11-08

    Wegmans Recalls Lemon Tart Filling for Undeclared Ingredients

    Wegmans is recalling 65 cases of Perfect Natural Lemon Tart Filling because the product contains undeclared FD&C Yellow 5, Yellow 6, Potassium Sorbate, and High Fructose Corn Syrup.

    Product
    549815- Fruit Fillings Inc. PERFECT NATURAL LEMON TART FILLING Net Weight 24 lb (10.88 kg) 12-2 lb tubes
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0079-2018·2017-11-08

    Wegmans Cheese Danish Twist Recalled for Undeclared Ingredients

    Wegmans is recalling Cheese Danish Twist products containing undeclared Yellow 5, Yellow 6, Potassium Sorbate, and High Fructose Corn Syrup.

    Product
    038267 - Wegmans Cheese Danish Twist, 13 oz. UPC: 0 77890 38267 7
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0061-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plate

    Smiths Medical is recalling CADD Medication Cassette Reservoirs that may have been manufactured with an incorrect pressure plate. The recall covers units distributed worldwide.

    Product
    CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (excep
    Category
    Medical Device
    Distribution
    Distributed nationwide