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.

7626–7650 of 21595

  • ModerateFDA (Devices)·Z-0709-2020·2019-12-25

    Angiodynamics Recalls OARTRAC Prostate Balloon Kits Due to Accuracy Issues

    Angiodynamics, Inc. is recalling 160 OARTRAC Prostate Immobilization Endorectal Balloon Device Kits because they may produce readings outside the expected accuracy range.

    Product
    OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0694-2020·2019-12-25

    Tekia Recalls Mislabeled Hydrophilic Acrylic Intraocular Lenses

    Tekia, Inc. is recalling 36 intraocular lenses that may be mislabeled with the incorrect diopter power. No U.S. distribution occurred.

    Product
    TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateUSDA FSIS·123-2019·2019-12-20

    Advance Pierre Foods Recalls Frozen Beef Patties Due to Plastic Contamination

    Advance Pierre Foods is recalling approximately 15,739 pounds of frozen, ready-to-eat beef patties that may contain small pieces of green soft plastic.

    Product
    AdvancePierre Foods, Inc. — Advance Pierre Foods Recalls Ready-to-Eat Ground Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateNHTSA·19V914000·2019-12-20

    Mercedes-Benz Recalls 2019 GLC Models for Incorrect Air Bag Labels

    Mercedes-Benz is recalling 2019 GLC models because passenger-side sun visors may have air bag warning labels in a foreign language, potentially obscuring safety risks.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLC63S, AMG GLC43, GLC 300, GLC350E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·122-2019·2019-12-20

    Ashland Sausage Recalls Pork Sausage Due to Possible Plastic Contamination

    Ashland Sausage Company is recalling approximately 1,092 pounds of Berkshire Natural Casing Sausage due to possible contamination with hard, dark plastic.

    Product
    Ashland Sausage Company — Ashland Sausage Co. Recalls Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0620-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the Spanish operator manual incorrectly states a 30-minute drying cycle, whereas 40 minutes are required for complete drying.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0613-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0597-2020·2019-12-18

    Anazao Health Recalls Clonidine, Baclofen, and Fentanyl Citrate Due to Fungal Contamination

    Anazao Health is recalling Clonidine HCL, Baclofen, and Fentanyl Citrate products due to the detection of Talaromyces rotundus fungi.

    Product
    Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0628-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0640-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recall for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0581-2020·2019-12-18

    Baclofen Recalled by Anazao Health Due to Fungal Contamination

    Anazao Health is recalling Baclofen products after environmental sampling detected Talaromyces rotundus, a type of fungus.

    Product
    Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0594-2020·2019-12-18

    Anazao Health Recalls Morphine, Fentanyl, and Baclofen Due to Fungal Contamination

    Coast Quality Pharmacy, LLC dba Anazao Health is recalling Morphine Sulfate, Fentanyl Citrate, and Baclofen products due to the detection of Talaromyces rotundus fungi.

    Product
    Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0646-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0651-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recall for Drying Time Discrepancy

    Integra LifeSciences is recalling C7000 CUSA Clarity systems because the operator manual lists a 30-minute drying time, but 40 minutes are required for complete drying.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Food)·F-0331-2020·2019-12-18

    Klein Foods Recalls Cookie Dough Fudge Due to Rubber Contamination

    Klein Foods is recalling 60 pounds of Cookie Dough Fudge because it may contain food-grade rubber pieces. The product was distributed in Minnesota and sold in the company's retail store.

    Product
    Klein Foods Cookie Dough Fudge, packed in 1/2 pound boxes
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0636-2020·2019-12-18

    AuroMedics Recalls Mirtazapine Tablets Due to Labeling Error

    AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets because some 500-count bottles are incorrectly labeled as 7.5 mg tablets.

    Product
    MIRTAZAPINE — MIRTAZAPINE (MIRTAZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0604-2020·2019-12-18

    Anazao Health Recalls Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL

    Anazao Health is recalling Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL due to environmental sampling revealing a fungus.

    Product
    Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0579-2020·2019-12-18

    Anazao Health Recalls Glutamine, Arginine, and Carnitine Vials Due to Fungal Contamination

    Anazao Health is recalling Glutamine/Arginine/Carnitine vials because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.

    Product
    Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0583-2020·2019-12-18

    Anazao Health Recalls Bupivacaine, Clonidine, and Hydromorphone Combination Injections

    Coast Quality Pharmacy is recalling Bupivacaine, Clonidine, and Hydromorphone injections due to fungal contamination found during environmental sampling.

    Product
    Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0638-2020·2019-12-18

    Integra CUSA Clarity Sterilization Tray Recall for Drying Time Error

    Integra LifeSciences is recalling CUSA Clarity 36 kHz Sterilization Trays because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0616-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0589-2020·2019-12-18

    FDA Recalls Hydromorphone and Bupivacaine Due to Fungal Contamination

    Coast Quality Pharmacy is recalling Hydromorphone HCL and Bupivacaine HCL products due to the detection of Talaromyces rotundus fungi during environmental sampling.

    Product
    Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0639-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states