The Recall Desk

Archive

December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical
72
Severe
272
High
309
Moderate
311
Low
64

Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 26% are Severe.

901–1000 of 1028

  • CriticalFDA (Food)·F-0552-2015·2014-12-03

    MaraNatha and Kroger Almond Butter Recalled for Salmonella Risk

    nSpired Natural Foods is recalling specific MaraNatha and Kroger almond butter products due to potential Salmonella contamination.

    Product
    MaraNatha No Stir Creamy Almond Butter, 12 oz., UPC 51651093682; MaraNatha No Stir Creamy Almond Butter, 340 grams, UPC 51651093453; Kroger No Stir Creamy Almond Butter, 12 oz., UPC 11110791214;
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0553-2015·2014-12-03

    MaraNatha Almond Butter Recalled for Potential Salmonella Contamination

    nSpired Natural Foods is recalling MaraNatha No Stir Raw Maple Creamy Almond Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.

    Product
    MaraNatha No Stir Raw Maple Creamy Almond Butter, 12 oz., UPC 51651093866.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0550-2015·2014-12-03

    MaraNatha and Whole Foods Almond Butter Recalled for Salmonella Risk

    nSpired Natural Foods is recalling specific almond butter products due to potential Salmonella contamination. The products were distributed in the US, Canada, and other countries.

    Product
    MaraNatha Roasted Creamy Almond Butter, 16 oz., UPC 51651060325; MaraNatha Roasted Creamy Almond Butter, 26 oz., UPC 51651092897; Whole Foods 365 Creamy Almond Butter, 16 oz., UPC 99482406578.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0539-2015·2014-12-03

    International Sprout Holding Recalls Alfalfa Seed for Salmonella

    International Sprout Holding Inc. is recalling 22,000 lbs of alfalfa seed because a sample tested positive for Salmonella. The product was distributed to multiple states and Canada.

    Product
    Alfalfa Seed in plastic lined bags labeled in part *** VNS Alfalfa, NET WT. 25 KG Lot SAL2-3BJ Product of AUSTRALIA, International Specialty Supply ***
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-0543-2015·2014-12-03

    Trader Joe's Raw Crunchy Almond Butter Recalled for Salmonella Risk

    nSpired Natural Foods is recalling Trader Joe's Raw Crunchy Almond Butter Unsalted due to potential Salmonella contamination. The product was distributed in the U.S., Canada, and other countries.

    Product
    Trader Joe's Raw Crunchy Almond Butter Unsalted, 16 oz., UPC 919890.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0578-2015·2014-12-03

    Kerry Foods Recalls Sage Sausage Seasoning Due to Salmonella Risk

    Kerry Foods is recalling specific lots of Sage Sausage Seasoning because the product contained an ingredient testing positive for Salmonella.

    Product
    Item Number 717548.01, Kerry 96002542, Sage Sausage Seasoning, 50 Lb (22.68 KG), Lots: 0329460107, 0428424311
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0561-2015·2014-12-03

    FDA Recalls Organic Peanut Butter for Potential Salmonella Contamination

    nSpired Natural Foods is recalling two brands of organic peanut butter due to potential Salmonella contamination. The products were distributed in the US, Canada, and other countries.

    Product
    MaraNatha Organic Roasted Creamy Peanut Butter, 16 oz., UPC 51651092197; Arrowhead Mills Organic Creamy Peanut Butter, 16 oz., UPC 74333470526.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0273-2015·2014-12-03

    Perry Drug Recalls Tri Mix Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling Tri Mix PF SYR 0.5 mL Inj. syringes in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.

    Product
    Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0279-2015·2014-12-03

    Hospira Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    Hospira is recalling 301,560 bags of 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0272-2015·2014-12-03

    Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG-20,000 U/2 mL vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0280-2015·2014-12-03

    Hospira Recalls IV Bags Due to Potential Sterility Breach

    Hospira is recalling 823,296 bags of 5% Dextrose and 0.45% Sodium Chloride Injection due to potential punctures that may compromise sterility.

    Product
    5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0270-2015·2014-12-03

    Perry Drug Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns

    Perry Drug Inc. is recalling HCG injections due to quality control issues that may compromise sterility assurance.

    Product
    2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0263-2015·2014-12-03

    Perry Drug Recalls Phenylephrine Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling specific lots of compounded Phenylephrine HCl syringes due to quality control issues affecting sterility assurance.

    Product
    Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0265-2015·2014-12-03

    Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG Low Dose vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0564-2015·2014-12-03

    MaraNatha Peanut Butter Recalled for Potential Salmonella Contamination

    nSpired Natural Foods is recalling MaraNatha No Stir Creamy Peanut Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.

    Product
    MaraNatha No Stir Creamy Peanut Butter, 16 oz., UPC 51651092210; MaraNatha No Stir Creamy Peanut Butter, 500 gram, UPC 51651093408.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0277-2015·2014-12-03

    Hospira Recalls Normosol-R IV Bags Due to Sterility Concerns

    Hospira is recalling 152,172 bags of Normosol-R IV solution due to potential punctures that may compromise sterility and cause leaks.

    Product
    Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0579-2015·2014-12-03

    Kerry Foods Recalls Sausage Crumble Due to Salmonella Risk

    Kerry Foods is recalling specific lots of Sausage Crumble because an ingredient tested positive for Salmonella.

    Product
    Item Number 30499117.0, Kerry CI 96004320, Sausage Crumble 30499117, 40.05 lbs (18.16 KG) Lot Number : 0401423904
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0281-2015·2014-12-03

    Hospira Recalls Lactated Ringer's and 5% Dextrose Injection Bags

    Hospira is recalling 275,448 bags of Lactated Ringer's and 5% Dextrose Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2015·2014-12-03

    Perry Drug Recalls Cyclosporine Eye Drops Due to Sterility Concerns

    Perry Drug Inc. is recalling Cyclosporine 0.045% eye drops due to potential sterility assurance issues identified during an FDA inspection.

    Product
    Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0572-2015·2014-12-03

    Karlsburger Foods Taco Seasoning Recalled for Undeclared Milk Allergen

    Karlsburger Foods is recalling specific items of Taco Seasoning because the product contains milk, an allergen not declared on the label.

    Product
    Karlsburger Foods Taco Seasoning, Item Numbers 43823 (Packaged in 23 oz resealable plastic containers), Item #43807 (Packaged in 7 lb. resealable plastic containers), Item #43825 (Packaged in 25 lb. bag in a box), and Item #43850 (Packaged in 50 lb. bag in a box).
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Devices)·Z-0472-2015·2014-12-03

    Toshiba Recalls Cardiac Function Analysis Software Due to Incorrect Results

    Toshiba American Medical Systems is recalling two units of cardiac function analysis software because it may display incorrect analysis results for heart function.

    Product
    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and perm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0278-2015·2014-12-03

    Hospira Recalls Potassium Chloride IV Bags Due to Sterility Concerns

    Hospira is recalling 836,460 bags of Potassium Chloride IV solution due to potential punctures that may compromise sterility and cause leaks.

    Product
    Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0573-2015·2014-12-03

    Karlsburger Foods Recalls Low Sodium Taco Seasoning for Undeclared Milk

    Karlsburger Foods is recalling Low Sodium Taco Seasoning because it contains milk, an allergen not declared on the label.

    Product
    Karlsburger Foods Low Sodium Taco Seasoning, Item Numbers 16423 (Packaged in 23 oz resealable plastic containers), Item #16465 (Packaged in 6.8 lb. resealable plastic containers), and Item #16425 (Packaged in 25 lb. bag in a box).
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Food)·F-0540-2015·2014-12-03

    nSpired Natural Foods Recalls Almond Butter for Salmonella Risk

    nSpired Natural Foods is recalling specific lots of MaraNatha and Whole Foods 365 almond butter due to potential Salmonella contamination.

    Product
    MaraNatha Roasted Crunchy Almond Butter, 16 oz., UPC 51651092012; Whole Foods 365 Crunchy Almond Butter, 16 oz.., UPC 99482406561.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0276-2015·2014-12-03

    Baxter Recalls Heparin Sodium Injection Due to Low Potency

    Baxter Healthcare is recalling Heparin Sodium in Sodium Chloride Injection because the raw material was found to have low potency.

    Product
    HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0287-2015·2014-12-03

    Hospira Recalls Sterile Water for Injection Due to Sterility Concerns

    Hospira is recalling 153,504 bags of Sterile Water for Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0554-2015·2014-12-03

    Safeway Almond Butter Recalled for Potential Salmonella Contamination

    nSpired Natural Foods is recalling Safeway Open Nature Creamy Almond Butter Salted due to potential Salmonella contamination. The product was distributed in the US, Canada, and other international locations.

    Product
    Safeway Open Nature Creamy Almond Butter Salted, 12 oz., UPC 79893113746
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0266-2015·2014-12-03

    Perry Drug Recalls Tri-mix Antidote Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling Tri-mix Antidote syringes in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.

    Product
    Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0283-2015·2014-12-03

    Hospira Recalls Lactated Ringer's Injection Due to Sterility Concerns

    Hospira is recalling 6,193,416 bags of Lactated Ringer's Injection because potential punctures may compromise sterility and cause leaks.

    Product
    Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0261-2015·2014-12-03

    Perry Drug Recalls Tri-Mix Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling 17 vials of compounded Tri-Mix in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0581-2015·2014-12-03

    Kerry Breakfast Sausage Seasoning Recalled for Salmonella Contamination

    Kerry Foods is recalling 148 bags of Breakfast Sausage Seasoning because an ingredient tested positive for Salmonella.

    Product
    Item Number B18780.01, Kerry Breakfast Sausage Seasoning, Net WT 50 Lb (22.68 KG), Lot Number: 0407424305
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0267-2015·2014-12-03

    Perry Drug Recalls HCG Vials Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG Low Dose vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0286-2015·2014-12-03

    Hospira Recalls 0.45% Sodium Chloride Injection Due to Sterility Concerns

    Hospira is recalling 784,920 bags of 0.45% Sodium Chloride Injection because punctures in the packaging may compromise sterility and cause leaks.

    Product
    0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0282-2015·2014-12-03

    Hospira Recalls 5% Dextrose and 0.9% Sodium Chloride Injection Bags

    Hospira is recalling 340,272 bags of 5% Dextrose and 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0268-2015·2014-12-03

    Perry Drug Recalls HCG Injection Vials Due to Sterility Concerns

    Perry Drug Inc. is recalling HCG 200 IU/mL Injection vials in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.

    Product
    HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7745-68
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0275-2015·2014-12-03

    Perry Drug Recalls Sodium Tetradecyl Sulfate Injections Due to Sterility Concerns

    Perry Drug Inc. is recalling 20 vials of compounded Sodium Tetradecyl Sulfate 0.3% Injection in Kansas and Missouri due to potential sterility assurance issues found during an FDA inspection.

    Product
    Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0284-2015·2014-12-03

    Hospira Recalls Normosol-R IV Bags Due to Sterility Concerns

    Hospira is recalling 305,664 bags of Normosol-R Multiple Electrolytes Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V770000·2014-12-03

    Chrysler Recalls 2004-2005 Vehicles Due to Air Bag Inflator Rupture Risk

    Chrysler is recalling 2004-2005 Dodge and Chrysler vehicles sold in high-humidity areas because the passenger air bag inflator may rupture during deployment.

    Product
    DODGE — DODGE, CHRYSLER RAM 3500, RAM 2500, MAGNUM, DURANGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0264-2015·2014-12-03

    Perry Drug Recalls Testosterone Cyp Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling Testosterone Cyp 200 mg/mL syringes due to quality control issues affecting sterility assurance.

    Product
    Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7906-71
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0269-2015·2014-12-03

    Perry Drug Recalls HCG Injections Due to Sterility Assurance Concerns

    Perry Drug Inc. is recalling HCG 10,000 U/10 mL PF Inj vials in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0260-2015·2014-12-03

    Perry Drug Recalls Methyl B12 Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling 186 prefilled syringes of Methyl B12 injection due to potential sterility assurance issues identified during an FDA inspection.

    Product
    Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0274-2015·2014-12-03

    Perry Drug Recalls Compounded HCG Injections Due to Sterility Concerns

    Perry Drug Inc. is recalling compounded HCG injections in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.

    Product
    HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0259-2015·2014-12-03

    Perry Drug Recalls Compounded Testosterone Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling compounded Testosterone CYP-250/PROP-20 mg syringes in Kansas and Missouri due to quality control issues affecting sterility assurance.

    Product
    Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-0560-2015·2014-12-03

    MaraNatha Peanut Butter Recalled for Potential Salmonella Contamination

    nSpired Natural Foods is recalling MaraNatha No Stir Crunchy Peanut Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.

    Product
    MaraNatha No Stir Crunchy Peanut Butter, 500 grams, UPC 51651093415.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0262-2015·2014-12-03

    Perry Drug Recalls Leuprolide Micro Lupron Kits Due to Sterility Concerns

    Perry Drug Inc. is recalling Leuprolide 50 mcg/0.1 mL Micro Lupron Kits in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.

    Product
    Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Food)·F-0577-2015·2014-12-03

    Kerry Foods Recalls Meatball Seasoning Due to Salmonella Risk

    Kerry Foods is recalling two meatball seasoning products because they were processed on equipment used for a product that tested positive for Salmonella.

    Product
    Kerry 52-0189-02 All Purpose Beef & Chicken Meatball Seasoning, Net WT 43.42 lbs (19.69 Kg) , B18517.01.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0440-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Cardiac Probe Grasper Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Cardiac Probe Graspers because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0441-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Large Hem-O-Lok Clip Applier Devices

    Intuitive Surgical is voluntarily recalling 509 units of 8mm Large Hem-O-Lok Clip Appliers due to a Class II device defect. The affected instruments were distributed to facilities in eight US states.

    Product
    8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0474-2015·2014-12-03

    Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Potential Result Errors

    Abbott Ireland Diagnostics Division is recalling 7,415 ARCHITECT Total T3 Reagent Kits because 17% of specific lots may produce patient results higher than expected.

    Product
    ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2015·2014-12-03

    Summit J700 X-Ray Tube Stand Recalled for Insufficient Welds

    Summit Industries is recalling 32 J700 Floor Mounted Tube Stands because insufficient welds may cause breakage, leading to equipment damage or injury.

    Product
    The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horiz
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0565-2015·2014-12-03

    Los Chileros Blue Corn Waffle Mix Recalled for Undeclared Wheat

    Los Chileros De Nuevo Mexico is recalling Blue Corn Waffle & Pancake Mix and six other products due to undeclared wheat.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Blue Corn Waffle & Pancake Mix, Net Wt. 16 oz (453.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Black Diamond Micro Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Black Diamond Micro Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0206-2015·2014-12-03

    Philips Medical Systems Recalls Gel-E and Squishon Baby Support Products Due to Mold

    Philips Medical Systems is recalling Gel-E Donut and Squishon 2 baby support products because mold was found on the gel-filled items.

    Product
    Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Monopolar Curved Scissors Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Monopolar Curved Scissors because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0421-2015·2014-12-03

    Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access

    Hospira Inc. is recalling GemStar infusion pumps because patients are using publicly available codes to change infusion rates set by doctors.

    Product
    GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0568-2015·2014-12-03

    Los Chileros Recalls Multiple Products Due to Undeclared Wheat

    Los Chileros De Nuevo Mexico is recalling seven food products, including cornbread and mixes, because they contain undeclared wheat.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Blue Cornbread, 9.84 oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Atrial Retractor Instruments Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Atrial Retractor Short Right instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0432-2015·2014-12-03

    Intuitive Surgical Recalls 8mm ProGrasp Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 8mm ProGrasp Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0485-2015·2014-12-03

    Respironics Esprit V1000 Ventilator Recall for Power Supply Defect

    Respironics is recalling Esprit V1000 and V200 Conversion Ventilators because incorrect screw installation may cause a short circuit, preventing the switch to battery power during AC outages.

    Product
    Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventila
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0567-2015·2014-12-03

    Los Chileros Recalls Seven Products Due to Undeclared Wheat

    Los Chileros De Nuevo Mexico is recalling seven food products, including Santa Fe Chile Seasoning, due to undeclared wheat.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Santa Fe Chile Seasoning, 4.5oz (127.6 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Curved Bipolar Dissectors Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Curved Bipolar Dissectors because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0446-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Clip Appliers Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm clip appliers because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0566-2015·2014-12-03

    Los Chileros Sopaipilla Mix Recalled for Undeclared Wheat

    Los Chileros De Nuevo Mexico is recalling Sopaipilla Mix and other products due to undeclared wheat, posing a risk to individuals with wheat allergies or celiac disease.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Sopaipilla Mix, Net Wt. 12 oz (340 grams), Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2015·2014-12-03

    Vision RT AlignRT System Recalled for Potential Interlock Failure

    Vision RT is recalling AlignRT systems due to a potential failure to assert interlock, which could affect radiation safety during treatment.

    Product
    AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0439-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Tenaculum Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Tenaculum Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0422-2015·2014-12-03

    Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access

    Hospira is recalling GemStar infusion pumps because patients are accessing dosage reset codes to change infusion rates set by doctors.

    Product
    GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Dual Blade Retractors for Reprocessing Issues

    Intuitive Surgical is recalling 509 units of 8mm Dual Blade Retractors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighNHTSA·14V769000·2014-12-03

    Nova Bus Recalls 2012 LFS Transit Buses Due to Seat Anchor Defect

    Nova Bus is recalling 2012 LFS transit buses because a seat anchor rivnut may not secure the seat properly, increasing injury risk if the seat detaches.

    Product
    NOVA BUS — NOVA BUS NOVA LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Large Needle Driver Instruments

    Intuitive Surgical is recalling 509 8mm Large Needle Driver instruments due to potential surface degradation and accelerated mechanical wear caused by reprocessing deviations.

    Product
    8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0471-2015·2014-12-03

    Toshiba Cardiac Function Analysis Software Recalled for Incorrect Results

    Toshiba American Medical Systems is recalling one unit of cardiac function analysis software in the US because it may display incorrect analysis results.

    Product
    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits sca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Potts Scissors Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 8mm Potts Scissors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0576-2015·2014-12-03

    Kerry Foods Recalls Meatball Seasoning Due to Salmonella Risk

    Kerry Foods is recalling two meatball seasoning products because they were processed on equipment used for sausage seasoning that tested positive for Salmonella.

    Product
    Kerry 52-0197-02, , Net Wt 39.7 lbs (18.00 Kg), B18516.01.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0551-2015·2014-12-03

    Almond Butter Recalled for Potential Salmonella Contamination

    nSpired Natural Foods is recalling specific almond butter products due to potential Salmonella contamination. Consumers should stop using and return the products.

    Product
    MaraNatha Organic Roasted Creamy Almond Butter, 16 oz., UPC 51651060219; Whole Foods 365 Organic Creamy Almond Butter, 16 oz., UPC 99482405960.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0544-2015·2014-12-03

    MaraNatha Almond Butter Recalled for Potential Salmonella Contamination

    nSpired Natural Foods is recalling MaraNatha No Stir Crunchy Almond Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.

    Product
    MaraNatha No Stir Crunchy Almond Butter, 12 oz., UPC 51651093699.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0419-2015·2014-12-03

    Gyrus ACMI Falope-Ring Band Applicator Kits Recalled for Sterile Packaging Compromise

    Gyrus Acmi is recalling Falope-Ring Band Applicator Kits due to sterile packaging compromises that could lead to bacterial contamination and patient infection.

    Product
    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2015·2014-12-03

    Philips IntelliSpace Portal Software Defect May Display Incorrect Cardiac Measurements

    Philips is recalling 32 IntelliSpace Portal systems due to a software defect that may display incorrect cardiac and aortic anatomy measurements used for sizing Transcatheter heart valves.

    Product
    IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0569-2015·2014-12-03

    Los Chileros Recalls Multiple Southwestern Food Products for Undeclared Wheat

    Los Chileros De Nuevo Mexico is recalling seven food products, including Carne Adovada and Sopaipilla Mix, due to undeclared wheat.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Carne Adovada with Sopaipilla Mix, 13 oz.., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0570-2015·2014-12-03

    Los Chileros Recalls Multiple Foods for Undeclared Wheat Allergen

    Los Chileros De Nuevo Mexico is recalling seven food products, including soups and mixes, due to undeclared wheat.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Cream of Green Chile Chicken Soup, 5.92 oz.., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0548-2015·2014-12-03

    MaraNatha Organic Raw Creamy Almond Butter Recalled for Salmonella Risk

    nSpired Natural Foods is recalling MaraNatha Organic Raw Creamy Almond Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.

    Product
    MaraNatha Organic Raw Creamy Almond Butter, 8 oz., UPC 51651092630; MaraNatha Organic Raw Creamy Almond Butter, 16 oz., UPC 51651092173.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0571-2015·2014-12-03

    Los Chileros Recalls Multiple Products Due to Undeclared Wheat

    Los Chileros De Nuevo Mexico is recalling seven food products, including Green Chile Stew with Tortilla Mix, because they contain undeclared wheat.

    Product
    Los Chileros de nuevo mexico gourmet southwestern cuisine Green Chile Stew with Tortilla Mix, 13oz., Los Chileros de Nuevo Mexico, PO Box 6215, Santa Fe, NM 87502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0589-2015·2014-12-03

    Marathon Ventures Recalls Macadamia Nuts Due to Salmonella Florida Contamination

    Marathon Ventures Inc. is recalling various brands of macadamia nuts nationwide due to possible contamination with Salmonella florida.

    Product
    Macadamia nuts in various formats: (1.) Western Family Macadamia Diced Nuts, Net Wt 5 oz. plastic bags Distributed by:Western Family Foods, Inc. Portland, OR UPC 0 15400 16635 5 (2.) Shur Fine Macadamia Diced Nuts, Net Wt 5 oz. plastic bags. Distributed by:Western Family Foo
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0285-2015·2014-12-03

    Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    Hospira is recalling 16.5 million bags of 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0433-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0430-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Long Tip Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Long Tip Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0424-2015·2014-12-03

    Zimmer Recalls Trabecular Metal Tibial Impactor Replacement Pads

    Zimmer, Inc. is recalling 4,961 Trabecular Metal Tibial Impactor Replacement Pads due to complaints of pad fracture. The recall provides clarifying instructions for assembly and disassembly.

    Product
    Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0445-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Small Grasping Retractor for Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of the 8mm Small Grasping Retractor because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0423-2015·2014-12-03

    Zimmer Recalls Trabecular Metal Tibial Impactor Pads Due to Fracture Complaints

    Zimmer, Inc. is recalling Trabecular Metal Tibial Impactor Pads to provide clarifying instructions on assembly and disassembly following complaints of pad fracture.

    Product
    Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0437-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Permanent Cautery Spatulas for Housing Degradation

    Intuitive Surgical is recalling 509 units of 8mm Permanent Cautery Spatulas because deviations in reprocessing steps can cause surface degradation of the housing and accelerate mechanical wear.

    Product
    8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0418-2015·2014-12-03

    Materialise Recalls Zimmer Patient Specific Instrument PERSONA CR Pin Guides

    Materialise USA LLC is recalling specific Zimmer Patient Specific Instrument PERSONA CR Pin Guides because the packaging contained incorrect components and one guide exceeded size specifications.

    Product
    Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2145-2014·2014-12-03

    Market-Tiers recalls laparoscopic morcellator instructions with missing safety pages

    Market-Tiers Inc. is recalling 100 units of the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System because the Instructions for Use omitted critical safety pages.

    Product
    Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0438-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Fenestrated Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0475-2015·2014-12-03

    Dharma Cavity Varnish Recalled for Lack of FDA Clearance

    Dharma Research, Inc. is recalling Dharma Cavity Varnish with Fluoride because the product was marketed without a cleared 510(k).

    Product
    Dharma Cavity Varnish with Fluoride
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0476-2015·2014-12-03

    Dharma Cavity Varnish Recalled for Missing FDA Clearance

    Dharma Research, Inc. is recalling Dharma Cavity Varnish 15mL because the product was marketed without a cleared 510(k) submission.

    Product
    Dharma Cavity Varnish 15mL
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0450-2015·2014-12-03

    Philips BrightView Ultrasound Systems Recalled for Software Issues

    Philips Medical Systems is recalling 85 BrightView ultrasound systems worldwide due to software issues. The voluntary recall was initiated in November 2014.

    Product
    BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0483-2015·2014-12-03

    Beevers Cannulaide Respirator Recalled for Improper Pouch Seal

    Beevers Manufacturing recalled Cannulaide respirators due to improper pouch seals that could affect device shelf life.

    Product
    Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0465-2015·2014-12-03

    Remel Recalls Legionella Pneumo Groups 2-14 Latex Test Kits

    Remel Inc is recalling specific lots of the Oxoid Legionella Pneumo Groups 2-14 Latex Test because a reagent may produce false negative results.

    Product
    Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of predomi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0574-2015·2014-12-03

    Sushi House Inc. Recalls Frozen Raw Yellowfin Tuna Ground Meat

    Sushi House Inc. is voluntarily recalling frozen raw yellowfin tuna ground meat because it may contain histamines exceeding 50 ppm.

    Product
    Frozen Raw Yellowfin Tuna Ground Meat (Thunnus albacares), Grade: AAA, Net Weight: 10 lbs (100%), Wild Caught, Product of Indonesia, Imported and distributed by Heartlight Seafood LLC, 429 SW 195th Ave., Pembroke Pines, FL 33029, Production Date: 06/10/2014, Best used by 06/10/20
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0256-2015·2014-12-03

    Baxter Recalls Potassium Chloride Injection Bags Due to Labeling Error

    Baxter Healthcare is recalling 63,360 bags of Potassium Chloride Injection due to incorrect outer packaging labels indicating a higher strength.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide

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