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.

11301–11325 of 21617

  • ModerateFDA (Drugs)·D-0363-2018·2018-02-21

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

    Sage Products Inc. is recalling Toothette Oral Care Daily Oral Cleansing Kits because they were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Toothette Oral Care Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse. Contains: 10 Petite Size Oral Swabs, individually wrapped, 1.5 fl oz/44ml bottle of Antiseptic Oral Rinse, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0822-2018·2018-02-21

    Walnut Creek Foods Caramel Popcorn Recalled for Missing Soy Labeling

    Walnut Creek Foods is recalling Caramel Popcorn because the label failed to list soy lecithin as an ingredient.

    Product
    WALNUT CREEK FOODS Caramel Popcorn NET WT 15 OZ (425g) Ingredients: Evaporated Can Juice, Popcorn, Butter (cream, salt), Salt, Sodium Bicarbonate, Cream of Tartar Contains: Milk Distributed by: Walnut Creek Foods, Walnut Creek, OH 44687 UPC 25555 99857 2
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0630-2018·2018-02-21

    Cook Inc. Recalls Central Venous Catheter Sets Due to Fit Issues

    Cook Inc. is recalling 85 Central Venous Catheter Sets because they may not fit over a guide wire, potentially causing procedure delays.

    Product
    Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J 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 blood p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0821-2018·2018-02-21

    Star Wars Caramel Popcorn Recalled for Grain Beetle Contamination

    Ross Acquisitions Company is recalling Star Wars tin caramel popcorn due to a customer report of grain beetles in the product.

    Product
    STAR WARS TIN WITH CARAMEL POPCORN NET WT 3.5 oz (99g) CONTAINS MILK AND SOY, MAY CONTAIN TREE NUTS AND PEANUTS DISTRIBUTED BY GALERIE HEBRON, KENTUCKY 41048 UPC 7 68395 51585 0
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-0395-2018·2018-02-21

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

    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.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 O
    Category
    Drug
    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 (Drugs)·D-0349-2018·2018-02-21

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

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

    Product
    Q Care, Oral Cleansing & Suctioning System Corinz. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 2 Or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2018·2018-02-21

    Sage Products Recalls Oral Cleansing Systems Due to Cross-Contamination

    Sage Products Inc. is recalling 25 cases of Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products.

    Product
    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 Packages Suction Oral Swab with sodium bicarbonate, Pe
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0602-2018·2018-02-21

    Arrow PICC Catheter Recall Due to Incorrect Component Kits

    Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or lumen configuration, potentially delaying patient treatment.

    Product
    ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0415-2018·2018-02-21

    Famciclovir Tablets Recalled Due to Temperature Abuse During Distribution

    Hetero Labs Limited is recalling 8,436 bottles of Famciclovir 500 mg tablets because high temperatures during distribution caused the tablets to become wet, stuck together, and disintegrated.

    Product
    FAMCICLOVIR — FAMCICLOVIR (FAMCICLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0358-2018·2018-02-21

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

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

    Product
    Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-S
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0614-2018·2018-02-21

    Siemens Artis one X-ray Systems Recalled for Monitor Display Issues

    Siemens is recalling Artis one fluoroscopic X-ray systems because the monitor display may blink or show a blue/black screen.

    Product
    Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray gener
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-0371-2018·2018-02-21

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

    Sage Products Inc. 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, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0620-2018·2018-02-21

    Aesculap ELAN 4 Drill Accessories Recalled for Lack of FDA Clearance

    Aesculap Implant Systems LLC is recalling ELAN 4 drill accessories because they were marketed without required FDA premarket notification clearance.

    Product
    ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING TWIS
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0390-2018·2018-02-21

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

    Sage Products Inc. is recalling Toothette Oral Care Suction Swabs because they were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Toothette Oral Care Suction Swabs with Perox-A-Mint solution. Contains 2 Suction Swabs 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 Code 6613
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0612-2018·2018-02-21

    Zimmer Surgical Recalls A.T.S. 4000TS Tourniquet Systems for Labeling Updates

    Zimmer Surgical Inc is recalling 8,231 A.T.S. 4000TS Tourniquet Systems to update on-device labels and operator manuals, and to reduce the required separation distance from RF communication equipment.

    Product
    A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0366-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Perox-A-Mint Due to Cross-Contamination

    Sage Products Inc. is recalling Toothette Oral Care Perox-A-Mint solution because it was manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

    Product
    Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6060 UPC (01)00618029800152
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0379-2018·2018-02-21

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

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

    Product
    Toothette Oral Care Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer, Contains 2 Suctino Swabs with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6513
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0400-2018·2018-02-21

    Sage Products Recalls Q.Care Oral Cleansing System 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 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 Suction Oral Swab packages with Perox-A-Mint s
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0566-2018·2018-02-21

    Medtronic Recalls Two Angled Drills Due to Tip Extension Discrepancy

    Medtronic is recalling two units of the ANGLED DRILL (REF 6630902) because the drill tip extension is longer than the printed specification indicates.

    Product
    Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0352-2018·2018-02-21

    Sage QCare Rx Oral Cleansing System Recalled for Cross-Contamination

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

    Product
    QCare Rx Oral Cleansing and 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-M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0572-2018·2018-02-21

    B. Braun Recalls PENCAN Spinal Anesthesia Trays Due to Foreign Matter

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

    Product
    PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0370-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Suction Toothbrushes

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

    Product
    Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction Toothbrushes with sodium bicarbonate. 0.25 fl oz/7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Produ
    Category
    Drug
    Distribution
    Distributed nationwide