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.

11726–11750 of 21617

  • ModerateFDA (Food)·F-0377-2018·2017-11-29

    Champion Foods Recalls Little Caesar's Meal Kits Due to Ink Pen Contamination

    Champion Foods is voluntarily recalling Little Caesar's Family Meal Kits and other bread products due to potential physical contaminants from an ink pen.

    Product
    Little Caesar's Family Meal Kits, Paper cartons, Contains: 1 pizza crust( 12 x 16), 1 package of pizza sauce, 1 package of cheese, 1 package of pepperoni, 1 Crazy bread Cust (18 pc), 1 packet of garlic buttery sauce, 1 packet of parmesan cheese, and 15 break n bake chocolate chip
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0094-2018·2017-11-22

    Siemens Symbia Intevo 6 SPECT/CT Software Recall for Data Input Error

    Siemens is recalling two Symbia Intevo 6 SPECT/CT systems because a software option may prevent users from modifying specific data input values during calibration.

    Product
    Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0104-2018·2017-11-22

    Terumo BCT Recalls Bone Marrow Procedure Packs Due to Labeling Errors

    Terumo BCT is recalling 281 bone marrow procedure packs because the patient labels contain incorrect lot numbers, catalog numbers, and expiration dates.

    Product
    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0098-2018·2017-11-22

    Karl Storz Recalls Mislabeled High Flow Insufflation Tubing Pouches

    Karl Storz Endoscopy is recalling 496 boxes of High Flow Insufflation Tubing because some inner pouches are mislabeled with the wrong catalog number.

    Product
    STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0103-2018·2017-11-22

    Terumo BCT Bone Marrow Procedure Pack Recall for Labeling Errors

    Terumo BCT is recalling specific bone marrow procedure packs because patient labels contain incorrect lot numbers, catalog numbers, and expiry dates.

    Product
    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0093-2018·2017-11-22

    Siemens Symbia Intevo 16 SPECT/CT Software Recall for Data Input Error

    Siemens is recalling two Symbia Intevo 16 SPECT/CT systems because a software option may prevent users from modifying specific data input values.

    Product
    Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPEC
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0097-2018·2017-11-22

    Smith & Nephew Recalls Intertan 10S Orthopedic Nails Due to Assembly Error

    Smith & Nephew is recalling 17 units of Intertan 10S orthopedic nails because the set screw was inserted upside down during manufacturing.

    Product
    smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-0372-2018·2017-11-22

    Performance Food Group Recalls Pasteurized Crabmeat Due to Temperature Abuse

    Performance Food Group is recalling specific cans of Chicken of the Sea and Jack's Catch pasteurized crabmeat due to potential temperature abuse during transit.

    Product
    Chicken of the Sea Pasteurized Crabmeat Lump Blend, Item #411820; Chicken of the Sea Pasteurized Crabmeat Claw, Item #370810; Jack's Catch Pasteurized Crabmeat Jumbo Lump Item #193980; Jack's Catch Pasteurized Crabmeat Lump, Item #199830. All packaged in 1 LB or 16 OZ tin cans.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0079-2018·2017-11-22

    Fagron Recalls Estriol Compounding Powder Due to Quality Assurance Deviations

    Fagron, Inc. is recalling Estriol for prescription compounding due to lack of quality assurance at the API manufacturer.

    Product
    Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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 (Food)·F-0350-2018·2017-11-15

    Harmless Harvest Recalls Probiotic Drinks Due to Premature 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 Strawberries; Coconut Cultured Beverage; UPC 859078-002566; Keep refrigerated 11 lf. oz. HDPE Bottle Ingredients: Organic Coconut Water, Water, Organic Coconut Meat, Organic Cane Sugar, Organic Strawberries, live and active cultures. Harmle
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0127-2018·2017-11-15

    San Gennaro Polenta Recalled for Unapproved Ink on Food Contact Surface

    San Gennaro Foods is recalling pre-cooked polenta because date coding ink was printed directly on the food contact surface of the packaging.

    Product
    Traditional Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 12/18 oz packages, UPC# 7-62676-15000-6 Traditional Polenta, San Gennaro brand, Pre-cooked Ready to Heat & Serve, 6/18oz packages, UPC# 7-62676-15000-6 Traditional Polenta, San Gennaro brand, Pre-coo
    Category
    Food
    Distribution
    18 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-0349-2018·2017-11-15

    Harmless Harvest Recalls Probiotic Drinks Due to Premature 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 Original; Coconut Cultured Beverage; UPC 859078-002542; Keep refrigerated 11 lf. oz. HDPE Bottle Ingredients: Organic Coconut Water, Water, Organic Coconut Meat, Organic Cane Sugar, live and active cultures. Harmless Harvest
    Category
    Food
    Distribution
    5 states
  • 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
  • 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 (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 (Food)·F-0124-2018·2017-11-15

    San Gennaro Recalls Green Chili Cilantro Polenta Due to Unapproved Ink

    San Gennaro Foods is recalling Green Chili Cilantro Organic Polenta because date coding ink was printed directly on the food contact surface, allowing contact with the product.

    Product
    Green Chili Cilantro Organic Polenta, Ancient Harvest brand, Pre-cooked ready-to-heat, 12/18oz packages, UPC# 6-59201-10204-6 Green Chili Cilantro Organic Polenta, Frieda's brand, Pre-cooked just heat & serve, 12/16oz packages, UPC# 0-37842-04158-8 Ingredients: Water, Org
    Category
    Food
    Distribution
    18 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
  • 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 (Food)·F-0120-2018·2017-11-15

    San Gennaro Foods Recalls Polenta Due to Non-Approved Ink Contact

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

    Product
    Traditional Organic Polenta, Ancient Harvest brand, Pre-cooked ready-to-heat, 12/18 oz packages UPC#6-59201-10201-5 Traditional Organic Polenta, Italissima brand, Ready to heat and serve, 12/24 oz packages UPC# 7-78518-00760-5 Traditional Organic Polenta, Frieda's brand, P
    Category
    Food
    Distribution
    18 states
  • 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 (Food)·F-0125-2018·2017-11-15

    San Gennaro Foods Recalls Quinoa Polenta Due to Non-Food-Grade Ink Contact

    San Gennaro Foods is recalling Ancient Harvest and Anna's Country Kitchen quinoa polenta because date coding ink was printed directly on the food contact surface of the packaging.

    Product
    Red & Black Quinoa Organic Polenta, Ancient Harvest brand, Pre-cooked ready-to-heat, 12/18oz packages, UPC# 6-59201-10207-7 Organic red & black quinoa polenta, Anna's Country Kitchen brand, Ready to heat and serve Pre-cooked, 12/24oz packages, UPC# 6-63221-10181-1 Ingredien
    Category
    Food
    Distribution
    18 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