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.

11351–11375 of 21617

  • ModerateFDA (Drugs)·D-0382-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Suction Toothbrushes

    Sage Products is recalling Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution due to potential cross-contamination with non-pharmaceutical products.

    Product
    Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction Toothbrushes with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6570
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0633-2018·2018-02-21

    Cook Inc. Recalls Central Venous Catheters Due to Fit Issues

    Cook Inc. is recalling specific lots of Central Venous Tray Triple Lumen Polyurethane Catheters because they may not fit over a guide wire, potentially causing procedure delays.

    Product
    Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0486-2018·2018-02-21

    Arrow Radial Artery Catheterization Set Recalled for Foreign Matter

    Arrow International Inc is recalling Radial Artery Catheterization Sets due to the presence of loose polypropylene foreign matter above release specifications.

    Product
    Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0605-2018·2018-02-21

    Beckman Coulter Recalls Unpaired Lyophilized Chemistry Calibrator Lots

    Beckman Coulter is recalling specific lots of lyophilized chemistry calibrators because unpaired lots were distributed, which may cause erroneous calibration results.

    Product
    Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based p
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Drugs)·D-0399-2018·2018-02-21

    Sage Q.Care Oral System Recalled for Cross-Contamination Risk

    Sage Products is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint s
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0404-2018·2018-02-21

    Sage Products Recalls Q.Care Oral Cleansing Systems Due to Cross-Contamination

    Sage Products Inc is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0797-2018·2018-02-21

    General Mills Recalls Larabar Chocolate Chip Cookie Dough Bars

    General Mills is recalling Larabar Chocolate Chip Cookie Dough bars because they may contain individually wrapped Coconut Cream Pie Bars.

    Product
    Larabar Chocolate Chip Cookie Dough, 5 - 1.6 oz (45g) bars Net Wt 8.0 oz(226g), UPC 21908-48817. Case UPC 000-21908-41675-5
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0355-2018·2018-02-21

    Sage Products Recalls Toothette Oral Swab System Due to Cross-Contamination

    Sage Products Inc. is recalling the Toothette Short Term Oral Swab System because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Toothette Short Term Oral Swab System with Perox-A-Mint Solution. Contains: 20 Individually wrapped Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44mL bottle of Perox-A-Mint solution and One (1) 0.5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Th
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0573-2018·2018-02-21

    B. Braun Recalls Spinal Anesthesia Kits Due to Foreign Matter

    B. Braun Medical is recalling Spinal & Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.

    Product
    Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0562-2018·2018-02-21

    Philips Ingenuity TF PET/CT Software Recall for Reconstruction Failures

    Philips is recalling 24 Ingenuity TF PET/CT systems due to a software defect that causes intermittent PET reconstruction failures, rendering acquired data unusable.

    Product
    Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0634-2018·2018-02-21

    Cook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Fit Issues

    Cook Inc. is recalling 304 Spectrum Central Venous Catheter Trays because the catheters may not fit over the guide wire, potentially causing procedure delays.

    Product
    Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemoth
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0392-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Suction Toothbrush Due to Cross-Contamination

    Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrush kits because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

    Product
    Toothette Oral Care Suction Toothbrush with Antiseptic Oral Rinse. Contains 1 Suction Toothbrush with sodium bicarbonate, 0.25 fl oz/ 7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Cod
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0597-2018·2018-02-21

    OrthoPediatrics Recalls 7.0mm Pedicle Screws Due to Color Anodizing Error

    OrthoPediatrics Corp is recalling 24 units of 7.0mm x 40mm pedicle screws because they were color anodized with the same color used for 5mm screws.

    Product
    Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0387-2018·2018-02-21

    Sage Products Recalls Oral Care Systems Due to Cross-Contamination

    Sage Products Inc. is recalling Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

    Product
    Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate, Pe
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0409-2018·2018-02-21

    Sage Q Care RX Oral System Recalled for Cross-Contamination Risk

    Sage Products is recalling Q Care RX Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

    Product
    Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 1 Single dose bottle of 0.12% CHG Oral Rinse, 2 Suction Oral Swab packages with Perox-A-Mint, 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0403-2018·2018-02-21

    Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination

    Sage Products is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0372-2018·2018-02-21

    Sage Products Recalls Q Care Oral Care Kits Due to Cross-Contamination

    Sage Products is recalling Q Care Continue Care kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6308 UPC 6 18029 83040 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0606-2018·2018-02-21

    Gibson Laboratories Recalls Blastomyces Antiserum Due to False Positives

    Gibson Laboratories LLC is recalling Blastomyces dermatitidis Antiserum vials because the product was reporting false positive results.

    Product
    Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0414-2018·2018-02-21

    FDA Recalls Bull Capsules Tainted with Sildenafil

    BYL Solutions Inc. is recalling Bull Capsules marketed without an approved NDA/ANDA and found to be tainted with sildenafil.

    Product
    Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0391-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Suction Toothbrush

    Sage Products is recalling Toothette Oral Care Suction Toothbrush kits due to cross-contamination with non-pharmaceutical products during manufacturing.

    Product
    Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution. Contains 1 Suction Toothbrush with sodium bicarbonate, 0.25 fl oz/ 7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Cod
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0384-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Suction Toothbrush Due to Cross Contamination

    Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrush kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Contains 1 Suction Toothbrush with sodium Bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab, Sage Products, Inc., 3909 Three Oaks Road, Cary,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0361-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care System Due to Cross-Contamination

    Sage Products Inc. is recalling the Toothette Oral Care Short Term Oral Care System because it was manufactured on equipment shared with non-pharmaceutical products.

    Product
    Toothette Oral Care Short Term Oral Care System with Perox-A-Mint solution, Contains 1.5 fl oz/44 ml bottle of Perox-A-Mint solution, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpaste, 1 Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three O
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0578-2018·2018-02-21

    Teva Recalls Fluoxetine Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals USA is voluntarily recalling Fluoxetine Tablets USP, 10 mg, because routine stability testing revealed an out-of-specification lactoside impurity.

    Product
    Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
    Category
    Drug
    Distribution
    0 states