The Recall Desk

Archive

February 2018 recalls

833 recalls were announced in February 2018.

What the numbers show

Critical
22
Severe
243
High
266
Moderate
281
Low
21

Of the 833 recalls this month scored against our rubric, 3% are Critical, 29% are Severe.

Which agencies issued them

301–400 of 833

  • 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…
    Category
    Medical Device
    Distribution
    4 states
  • 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 (Drugs)·D-0388-2018·2018-02-21

    Sage Products Recalls Oral Cleansing System Due to Cross-Contamination

    Sage Products Inc. is recalling 20 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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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…
    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 (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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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…
    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 (Devices)·Z-0621-2018·2018-02-21

    Aesculap ELAN 4 Burr and Blade Accessories Recalled for Regulatory Violation

    Aesculap Implant Systems LLC is recalling ELAN 4 burr and blade accessories because they were marketed without 510(k) premarket notification clearance.

    Product
    ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN…
    Category
    Medical Device
    Distribution
    4 states
  • 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 (Devices)·Z-0604-2018·2018-02-21

    Synthes Recalls Titanium Trochanteric Fixation Nails Due to Missing Components

    Synthes (USA) Products LLC is recalling 4 units of sterile titanium trochanteric fixation nails because the locking mechanism and protective cap were missing.

    Product
    11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
    Category
    Medical Device
    Distribution
    4 states
  • 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 (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…
    Category
    Drug
    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 (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-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-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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0632-2018·2018-02-21

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

    Cook Inc. is recalling 75 central venous catheter sets because they may not fit over a guide wire, potentially causing procedure delays.

    Product
    Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or…
    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.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0410-2018·2018-02-21

    Sage Products Recalls Chlorhexidine Skin and Oral Care Kits

    Sage Products Inc. is recalling 150 cases of skin antisepsis and oral cleansing kits due to cross-contamination risks from shared manufacturing equipment.

    Product
    Skin antisepsis and oral cleansing. Contains Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0373-2018·2018-02-21

    Sage Products Recalls Q CARE Oral Cleaning System Due to Cross-Contamination

    Sage Products is recalling Q CARE q4 Oral Cleaning & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Q CARE q4 Oral Cleaning & Suctioning System Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6404…
    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-0401-2018·2018-02-21

    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.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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0350-2018·2018-02-21

    Sage Products Recalls Toothette Oral Care Perox-A-Mint Solution

    Sage Products is recalling Toothette Oral Care Perox-A-Mint Solution packets due to cross-contamination with non-pharmaceutical products during manufacturing.

    Product
    Toothette Oral Care Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packet. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6065. UPC 6 18029 80018 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-0575-2018·2018-02-21

    B. Braun Recalls Pain Management Trays with Foreign Matter

    B. Braun Medical is recalling 460 Pain Management Trays containing 22GA SafetyGlide Needles due to the presence of loose polypropylene foreign matter.

    Product
    Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0623-2018·2018-02-21

    Aesculap ELAN 4 Air System Recalled for Premarket Clearance Issues

    Aesculap Implant Systems LLC is recalling 167 units of the ELAN 4 Air System because they were released to the market before receiving FDA 510(k) clearance.

    Product
    The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
    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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0796-2018·2018-02-21

    Kingston Pharma Recalls Live Better Black Elderberry Syrup Due to Gas Development

    Kingston Pharma LLC is recalling 13,536 bottles of Live Better Drug Free Black Elderberry Syrup because gas is developing in the sealed bottles.

    Product
    Live Better Drug Free Black Elderberry Syrup, 4 FL OZ (118 mL); DIETARY SUPPLEMENT, UPC 050428581186
    Category
    Food
    Distribution
    11 states
  • 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 (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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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…
    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
  • 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-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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0567-2018·2018-02-21

    B. Braun Recalls Perifix Anesthesia Kits Due to Foreign Matter

    B. Braun Medical is recalling Perifix Continuous Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter.

    Product
    Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0389-2018·2018-02-21

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

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

    Product
    Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Perox-A-Mint solution, 10 Suction Oral Swab packages with Perox-A-Mint solution, 4 Oropharyngeal Suction Catheter packages. Sage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0421-2018·2018-02-21

    BonaDur For Men Lidocaine Spray Recalled for Manufacturing Deviations

    Webrx dba RxPalace.com is recalling BonaDur For Men lidocaine spray because it was not manufactured according to current good manufacturing practices.

    Product
    BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0574-2018·2018-02-21

    B. Braun Recalls Epidural Anesthesia Kits Due to Foreign Matter

    B. Braun Medical is recalling 120 units of Customer Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter.

    Product
    Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0354-2018·2018-02-21

    Sage Products Recalls QCare RX Oral Cleansing System Due to Cross-Contamination

    Sage Products is recalling 9,006 cases of QCare RX Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products.

    Product
    QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 10 Suction Oral Swab packages with…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0615-2018·2018-02-21

    Pentax Video Cystoscopes Recalled for Lack of FDA Clearance

    Pentax of America Inc is recalling 24 Video Cystoscopes because they lack required FDA premarket notification clearance.

    Product
    Video Cystoscope models ECY-1570 and ECY-1570K
    Category
    Medical Device
    Distribution
    9 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…
    Category
    Medical Device
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2018·2018-02-21

    Zimmer Surgical Recalls A.T.S. 2200TS Tourniquet Systems for Labeling Updates

    Zimmer Surgical is recalling 8,231 A.T.S. 2200TS Tourniquet Systems to update on-device labels and operator manuals regarding RF communication equipment separation distances.

    Product
    A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 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 (Food)·F-0811-2018·2018-02-21

    Improper Goods Recalls Hibiscus Lavender Syrup Due to Temperature Issue

    Improper Goods is recalling Hibiscus Lavender Syrup because production records showed the internal fill temperature was below 165°F.

    Product
    Hibiscus Lavender Syrup, packaged in 100 mL or 250 mL glass bottle. 100 mL bottle has UPC 8 53142 00505 7. 250 mL bottle has UPC 8 53142 00507 1. These bottles are also sold in the following cocktail kits: -Portland Pony -Dark and Stormy -Whiskey Ginger Smash -Sun Hat…
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0369-2018·2018-02-21

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

    Sage Products Inc. is recalling 879 cases of Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml Antiseptic Oral Rinse, 0.7 fl oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013.…
    Category
    Drug
    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…
    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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0576-2018·2018-02-21

    B. Braun Recalls Contiplex Nerve Block Trays Due to Foreign Matter

    B. Braun Medical is recalling 300 Contiplex Nerve Block Trays because they contain needles with loose polypropylene foreign matter above release specifications.

    Product
    Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0367-2018·2018-02-21

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

    Sage Products Inc. is recalling 2,548 cases of Toothette Oral Care Short Term Oral Swab Systems because they were manufactured on equipment shared with non-pharmaceutical products.

    Product
    Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 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 (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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0413-2018·2018-02-21

    Allergan Recalls NORCO Tablets Due to Missing Controlled Substance Labeling

    Allergan is recalling 8 bottles of NORCO tablets because the primary label is missing the required CII controlled drug classification indication.

    Product
    NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0416-2018·2018-02-21

    Genentech Recalls Klonopin Tablets Due to Missing Schedule IV Labeling

    Genentech is recalling Klonopin (clonazepam) 0.5 mg tablets because the Schedule IV controlled substance indicator was omitted from the product carton.

    Product
    Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0616-2018·2018-02-21

    AMEDA Recalls Purely Yours Breast Pumps Due to Incorrect Power Adapter

    AMEDA is recalling specific lots of Purely Yours Breast Pumps because they were manufactured with a UK power adapter instead of the correct one.

    Product
    Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Drugs)·D-0417-2018·2018-02-21

    Sun Pharmaceutical Recalls Azelastine HCl Nasal Spray for Stability Test Failure

    Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution 0.1% because it failed a droplet size stability test. The recall covers 17,554 bottles distributed nationwide.

    Product
    AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V126000·2018-02-20

    Kaufman Double Deck Car Hauler Recalled for Axle Spindle Defect

    Kaufman is recalling 2018 Double Deck Car Hauler trailers because incorrect axle spindles may fail, causing wheel detachment and increasing crash risk.

    Product
    KAUFMAN — KAUFMAN DOUBLE DECK CAR HAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·012-2018·2018-02-20

    Night Hawk Recalls Frozen Beef Patties for Undeclared Milk Allergen

    Night Hawk Frozen Foods is recalling approximately 167 pounds of frozen beef patty and gravy products because they contain undeclared milk, a known allergen.

    Product
    Night Hawk Frozen Foods, Inc. — Night Hawk Frozen Foods, Inc. Recalls Frozen Beef Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·18V124000·2018-02-20

    Navistar Recalls 2016-2019 IC Bus CE School Buses for Relay Defect

    Navistar is recalling 2016-2019 IC Bus CE school buses with 8.8L LPG engines because a relay may fail, causing the fuel pump to stop and the bus to stall.

    Product
    IC BUS — IC BUS CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V114000·2018-02-19

    Karma Revero Recalled for Side Air Bag Detachment Risk

    Karma Automotive is recalling 2018 Revero vehicles because side curtain air bags may partially detach during deployment, increasing injury risk in a crash.

    Product
    KARMA — KARMA REVERO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V119000·2018-02-19

    Hino Recalls 2018-2019 Trucks Due to Loose Fuse Terminal Bolts

    Hino is recalling 2018-2019 NE8J, NH8J, NJ8J, and NV8J trucks because loose fuse terminal bolts may cause electrical arcing, overheating, or engine shutdown.

    Product
    HINO — HINO NE8J, NH8J, NJ8J, NV8J
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V121000·2018-02-19

    Keystone Recalls 2018 Crossroads Trailers Due to Electrical Fire Risk

    Keystone RV is recalling 2018 Crossroads Zinger and Longhorn trailers because an improperly installed ground wire may cause an electrical short and fire.

    Product
    CROSSROADS — CROSSROADS LONGHORN, ZINGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V120000·2018-02-19

    Thor Motor Coach Recalls Outlaw RVs Due to Seat Belt Bracket Defect

    Thor Motor Coach is recalling 2018-2019 Outlaw model 29J recreational vehicles because the sofa seat belt bracket may not meet strength requirements, increasing injury risk in a crash.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH OUTLAW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V118000·2018-02-17

    Hyundai Recalls 2018 Santa Fe Vehicles Due to Steering Wheel Defect

    Hyundai is recalling 2018 Santa Fe and Santa Fe Sport vehicles because the steering wheel assembly may break and separate from the column while driving.

    Product
    HYUNDAI — HYUNDAI SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V117000·2018-02-17

    Nova Bus Recalls 2013 LFS Transit Buses for Cooling System Defect

    Nova Bus is recalling 2013 LFS transit buses because a transmission oil cooler failure could cause hot coolant to leak into the passenger area, posing a risk of injury.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·011-2018·2018-02-16

    Pilgrim's Pride Recalls Breaded Chicken Patties Due to Rubber Contamination

    Pilgrim's Pride is recalling ready-to-eat breaded chicken patties that may contain rubber. The recall affects approximately 101,310 pounds shipped to institutions nationwide.

    Product
    Pilgrim's Pride Corporation — Pilgrim's Pride Corporation Recalls Ready-to-Eat Chicken Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V116000·2018-02-16

    Freightliner MT45G and MT55G Recalled for Electrical Fire Risk

    Daimler Trucks North America is recalling 2018 Freightliner MT45G and MT55G vehicles because a capacitor bracket may cause an electrical short, increasing the risk of fire.

    Product
    FREIGHTLINER — FREIGHTLINER MT55G, MT45G
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18100·2018-02-15

    Rural King Recalls Electric Blankets and Throws Due to Fire and Burn Hazards

    Rural King is recalling electric heated blankets and throws because the cords can overheat, posing fire and burn risks. Consumers should stop using the products and contact the company for a refund.

    Product
    Electric heated blankets and throws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V113000·2018-02-15

    Mercedes-Benz Recalls Sprinter Vans Due to Incorrect Weight Labels

    Daimler Vans USA is recalling 2016-2017 Mercedes-Benz Sprinter 2500 and 3500 vans with folding seats because the unloaded vehicle weight label may be incorrect, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 3500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0764-2018·2018-02-14

    Polvorones Recalled for Undeclared Soy and Wheat Allergens

    Productos Pacheco, Inc. is recalling Polvorones NET WT 4OZ due to undeclared soy and wheat allergens. The product was distributed to consignees in Puerto Rico.

    Product
    Polvorones NET WT 4OZ
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0792-2018·2018-02-14

    Brenckle Farms Recalls Fresh Cilantro Due to Listeria Risk

    Brenckle Farms is recalling fresh cilantro from Hartville, Ohio, after being notified that the product contains Listeria monocytogenes.

    Product
    Fresh Cilantro BRENCKLE FARMS INC Hartville, Ohio
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0337-2018·2018-02-14

    AuroMedics Recalls Linezolid Injection Bags Due to Mold Contamination

    AuroMedics Pharma LLC is recalling 9,050 bags of Linezolid Injection 600 mg/300 mL because white particulate matter identified as mold was found in one bag.

    Product
    LINEZOLID — LINEZOLID (LINEZOLID)
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Food)·F-0805-2018·2018-02-14

    Panera Plain Cream Cheese Recalled for Listeria Contamination Risk

    Panera, LLC is recalling Plain Cream Cheese in 2 oz. and 8 oz. sizes due to potential Listeria monocytogenes contamination. The product was sold nationwide at Panera Cafes.

    Product
    Panera Plain Cream Cheese, 2 oz. and 8 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0807-2018·2018-02-14

    Panera Cream Cheese Recalled Over Listeria Contamination Risk

    Panera is recalling Reduced-Fat Honey Walnut Cream Cheese due to potential Listeria monocytogenes contamination. The product was sold nationwide at Panera Cafes.

    Product
    Panera Reduced-Fat Honey Walnut Cream Cheese, 2 oz. and 8 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0808-2018·2018-02-14

    Panera Recalls Reduced-Fat Wild Blueberry Cream Cheese Due to Listeria Risk

    Panera, LLC is recalling Reduced-Fat Wild Blueberry Cream Cheese because it may be contaminated with Listeria monocytogenes. The product was sold nationwide at Panera Cafes.

    Product
    Reduced-Fat Wild Blueberry Cream Cheese, 2 oz. and 8 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0774-2018·2018-02-14

    Bulletproof Collagen Protein Recalled for Undeclared Milk Allergen

    Bulletproof 360 Inc is recalling Unflavored Collagen Protein because the product contains undeclared milk. The item is mislabeled as collagen protein but actually contains whey protein.

    Product
    Bulletproof Unflavored Collagen Protein High Performance Building Blocks Dietary Supplement, packaged in a 16-oz. composite-film bag, UPC: 8 15709 02115 3. The label is read in parts: "***COLLAGEN PROTEIN***Ingredients: Hydrolyzed collagen powder***Processed in a facility…
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Drugs)·D-0339-2018·2018-02-14

    Aurobindo Recalls Ampicillin and Sulbactam Injection Due to Glass Particulates

    Aurobindo Pharma is recalling 53,040 vials of Ampicillin and Sulbactam for Injection due to a confirmed report of visible glass particulate matter.

    Product
    AMPICILLIN AND SULBACTAM — AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0340-2018·2018-02-14

    AuroMedics Recalls Pantoprazole Sodium Injection Due to Glass Particulate

    AuroMedics Pharma LLC is recalling 66,100 vials of Pantoprazole Sodium for Injection because one vial contained a piece of glass.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0768-2018·2018-02-14

    Vanilla Cake with Cheese Recalled for Undeclared Allergens

    Productos Pacheco, Inc. is recalling Vanilla Cake with Cheese due to undeclared allergens including wheat, soy, milk, and food dyes.

    Product
    Bizcocho de Vainilla con Queso [Vanilla Cake with Cheese] NET WT 4OZ and 12OZ
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0804-2018·2018-02-14

    Panera Chive and Onion Cream Cheese Spread Recalled for Listeria Risk

    Panera, LLC is recalling Chive & Onion Reduced Fat Cream Cheese Spread due to potential Listeria monocytogenes contamination.

    Product
    Panera Chive&Onion Reduced Fat Cream Cheese Spread, 2 oz. and 8 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0702-2018·2018-02-14

    Frog Holler Recalls Cherry Tomatoes for Potential Salmonella Contamination

    Frog Holler Ltd. is voluntarily recalling cherry tomatoes in pint clamshells due to potential Salmonella contamination. The product was distributed in Michigan between January 4 and 10, 2018.

    Product
    Cherry Tomatoes, packaged in a pint sized plastic clamshell, no labeling
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0757-2018·2018-02-14

    Mountain Rose Recalls Prickly Ash Bark Powder Due to Salmonella Risk

    Mountain Rose Inc is recalling Prickly Ash Bark Powder herbal supplements due to potential Salmonella contamination. The product was distributed in 30 states.

    Product
    Prickly Ash Bark Powder Herbal Supplement, packaged in food grade stand up plastic pouches or plastic bags depending on quantity ordered, various net weights - 1-oz., 4-oz., 8-oz., 1-lb., 2-lb., 5-lb., 7-lb., 11-lb., 15-lb., and 16-lb. The label is read in parts: "***Prickly…
    Category
    Food
    Distribution
    29 states
  • SevereFDA (Devices)·Z-0508-2018·2018-02-14

    Siemens Artis Biplane Systems Recalled for Ceiling Mount Defect

    Siemens is recalling 265 Artis zee and Artis Q biplane systems because ceiling mount screws may not be fastened correctly.

    Product
    AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0559-2018·2018-02-14

    Recall of Emprint Percutaneous Antenna Due to Tip Disengagement Risk

    FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
    Category
    Medical Device
    Distribution
    Distributed nationwide

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