The Recall Desk

Archive

June 2016 recalls

896 recalls were announced in June 2016.

What the numbers show

Critical
58
Severe
216
High
442
Moderate
156
Low
24

Of the 896 recalls this month scored against our rubric, 6% are Critical, 24% are Severe.

Which agencies issued them

701–800 of 896

  • CriticalFDA (Drugs)·D-0879-2016·2016-06-01

    Pink Bikini Strong Formula capsules recalled for undeclared ingredients

    Lucy's Weight Loss System is recalling Pink Bikini Strong Formula capsules because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA/ANDA.

    Product
    Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0870-2016·2016-06-01

    Avastin Syringes Recalled for Bacterial Contamination

    AmEx Pharmacy is recalling 836 Avastin syringes nationwide because testing revealed bacterial contamination.

    Product
    Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0871-2016·2016-06-01

    Pharmakon Recalls Morphine Sulfate Syringes Due to High Potency

    Pharmakon Pharmaceuticals is recalling 75 syringes of Morphine Sulfate 0.5 mg/mL due to out-of-specification potency results indicating high levels.

    Product
    Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0860-2016·2016-06-01

    Lipo Escultura capsules recalled for containing unapproved prescription drugs

    Lipo Escultura capsules are being recalled because they contain sibutramine and diclofenac, making them unapproved drugs rather than dietary supplements.

    Product
    LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0890-2016·2016-06-01

    FDA Recalls Bull Capsules Marketed Without FDA Approval

    R Thomas Marketing, LLC is recalling Bull capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V391000·2016-06-01

    KZRV Recalls 2016 MXT Travel Trailers Due to Underrated Safety Chains

    KZRV is recalling 2016 MXT travel trailers because the safety chains are rated for less weight than the vehicle's gross weight rating, posing a crash risk if the main connection fails.

    Product
    KZRV — KZRV MXT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1384-2016·2016-06-01

    Unlabeled Dried Yellow Fish Recalled for Being Uneviscerated

    WD Import and Export Inc. is recalling 2 cases of unlabeled, whole dried yellow fish from China found to be uneviscerated.

    Product
    Whole Dried Yellow Fish in bulk cardboard box, unlabeled, Product of China --- Fish measured 6.5 - 7.5 inches in length
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V382000·2016-06-01

    Audi Recalls A4 and A6 Vehicles Due to Air Bag Inflator Rupture Risk

    Volkswagen Group of America is recalling specific Audi A4 and A6 models because passenger air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    AUDI — AUDI A4, A6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1381-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Ingredients

    The Sausage Maker, Inc. is recalling Summer Sausage seasoning due to undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Summer Sausage under the following labels: 1) Net Wt 8 oz, 2) Net Wt 2 lbs. 8 oz., 3 ) Net Wt 25 lbs, 4) Summer Sausage Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0889-2016·2016-06-01

    African Black Ant capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling African Black Ant capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0865-2016·2016-06-01

    Hospira Recalls Sodium Bicarbonate Injection Due to Insect Particulate Matter

    Hospira Inc. is recalling 72,000 units of 8.4% Sodium Bicarbonate Injection because an insect was found in one vial.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0868-2016·2016-06-01

    Teva Recalls Linezolid Injection Bags Due to Sterility Concerns

    Teva North America is recalling 546 bags of Linezolid Injection due to potential leaking that compromises sterility.

    Product
    Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hung
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·16185·2016-06-01

    Traxxas Recalls X-Maxx Monster Trucks and Speed Controls for Fire Hazard

    Traxxas is recalling X-Maxx Monster Trucks and VXL-6 electronic speed controls because a short circuit can cause a fire. The company reported 40 fires and one injury.

    Product
    X-Maxx Monster Trucks and VXL-6 electronic speed controls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0859-2016·2016-06-01

    Teva Recalls Amikacin Sulfate Injection Due to Glass Particulate Matter

    Teva Pharmaceuticals USA is recalling Amikacin Sulfate injection vials because glass particulate matter was identified in one vial.

    Product
    Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0867-2016·2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi USA is recalling Octreotide Acetate Injection vials because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1379-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Allergens

    The Sausage Maker, Inc. is recalling Goetburg Summer Sausage seasoning due to undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Goetburg Summer Sausage under the following labels: 1) Net Wt: 2 lbs.8 oz, 2) Goteborg Summer Sausage Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0892-2016·2016-06-01

    FDA Recalls Unapproved Zhong Hua Niu Bian Capsules Nationwide

    R Thomas Marketing, LLC is recalling Zhong Hua Niu Bian capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0861-2016·2016-06-01

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 282,080 bags of 0.9% Sodium Chloride Injection USP due to a lack of assurance of sterility caused by potential container leaks.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0872-2016·2016-06-01

    Sanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System

    Sanofi-Aventis is recalling Auvi-Q epinephrine auto-injectors because a defective delivery system may result in inaccurate dosage delivery.

    Product
    Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1284-2016·2016-06-01

    Aloha Medicinals Recalls Organic Dried Mushroom Powder Due to E. coli

    Aloha Medicinals is recalling organic dried mushroom powder after a sample tested positive for E. coli following customer reports of stomach issues.

    Product
    Organic Auricularia auricular (Dried Mushroom Powder (Jelly Ear Mushroom). 60 kg 4 mil polyethylene bags inside plastic polyethylene black drum. Certified Organic by QAI - Made in USA. Aloha Medicinals Inc. 2300 Arrowhead Drive Carson City, NV 89706
    Category
    Food
    Distribution
    0 states
  • SevereCPSC·16749·2016-06-01

    Mohu Recalls BeBox Smart Boomboxes Due to Burn and Fire Hazards

    Mohu is recalling about 1,700 BeBox smart boomboxes because they can overheat, posing burn and fire hazards. One incident of a unit catching fire was reported, with no injuries.

    Product
    Boombox
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0898-2016·2016-06-01

    Happy Passengers Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Happy Passengers capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0901-2016·2016-06-01

    Man King capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Man King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0902-2016·2016-06-01

    FDA Recalls Mojo Risen Distributed Without Approved New Drug Application

    R Thomas Marketing, LLC is recalling Mojo Risen capsules nationwide because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0885-2016·2016-06-01

    Herb Viagra Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Herb Viagra because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E051000·2016-06-01

    M.B. Sturgis Recalls Auto Changeover Propane Gas Regulators Due to Leak Risk

    M.B. Sturgis is recalling specific propane gas regulators where a cracked window may allow gas to leak, increasing fire risk. Dealers will replace the parts free of charge.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0876-2016·2016-06-01

    Akorn Recalls PerioRx Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling PerioRx oral rinse because multiple batches failed impurity specifications. The product contains an unknown impurity of chlorhexidine gluconate.

    Product
    PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0906-2016·2016-06-01

    FDA Recalls Super Hard Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Super Hard capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0896-2016·2016-06-01

    FDA Recalls Black Storm Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Black Storm capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0907-2016·2016-06-01

    FDA Recalls Zhen Gong Fu for Lack of Approved New Drug Application

    R Thomas Marketing, LLC is recalling Zhen Gong Fu capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0891-2016·2016-06-01

    Bull's Genital Recalled for Marketing Without FDA Approval

    R Thomas Marketing, LLC is recalling Bull's Genital capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0899-2016·2016-06-01

    Plant Vigra Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Plant Vigra because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0893-2016·2016-06-01

    FDA Recalls African Superman Supplements Marketed Without Approval

    R Thomas Marketing, LLC is recalling African Superman supplements because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0886-2016·2016-06-01

    Real Skill Recalled for Marketing Without FDA Approval

    R Thomas Marketing, LLC is recalling Real Skill capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0884-2016·2016-06-01

    FDA Recalls Black Ant Supplements Marketed Without Approval

    The FDA is recalling Black Ant supplements distributed by R Thomas Marketing, LLC because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0866-2016·2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi is recalling specific lots of Octreotide Acetate Injection because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1792-2016·2016-06-01

    American Surgical Delicot X Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Delicot X sponges due to packaging defects that compromise sterility. The recall covers 3 boxes distributed worldwide.

    Product
    American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1759-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 34 boxes of strung cotton balls due to packaging defects that compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1823-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling specific trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0903-2016·2016-06-01

    Night Man capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Night Man capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility.

    Product
    Various trauma and sports medicine instruments and implants. Bit, drill.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 4 cases distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V390000·2016-06-01

    Pierce Emergency Vehicles Recalled for Improperly Soldered Pump Strainers

    Pierce is recalling 2015-2016 emergency vehicles because pump intake strainers may be improperly soldered, risking pump damage and reduced firefighting effectiveness.

    Product
    PIERCE — PIERCE IMPEL, SABER, VELOCITY, ENFORCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1770-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 102 boxes of Ray-Cot 1" x 1" sponges because defective packaging compromises sterility.

    Product
    American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1391-2016·2016-06-01

    Kraft Heinz Recalls CapriSun Fruit Punch Due to Glass Fragments

    Kraft Heinz is recalling CapriSun fruit punch roarin'waters because of the possible presence of glass fragments. Consumers should stop using the affected products.

    Product
    CapriSun fruit punch roarin'waters packaged in a blue and white box with pictures of fruit and white lettering.
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·16V386000·2016-06-01

    Forest River Recalls Transit Buses with Defective Wheelchair Lifts

    Forest River is recalling specific transit buses equipped with Ricon wheelchair lifts due to a risk of platform separation and injury to operators.

    Product
    STARTRANS — STARTRANS, STARCRAFT BUS, GLAVAL BUS SENATOR II HD, QUEST, QUEST XL, SENATOR II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 23 boxes of Ultracot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. guide, surgical, instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility.

    Product
    Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1808-2016·2016-06-01

    American Surgical Policot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2016·2016-06-01

    Biomet Recalls Trauma and Spinal Implants Due to Sterile Seal Defects

    Biomet is recalling various trauma, sports medicine, and spinal implants because insufficient seal strength may compromise sterility, potentially leading to infection.

    Product
    Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1378-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Allergens

    The Sausage Maker, Inc. is recalling specific seasoning products because they contain undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Dried Sticks Hot under the following labels: 1) Net Wt 2 lbs, 2) Net Wt 25 lbs, 3) Hot Dried Sausage Sticks Kit w/19mm
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1636-2016·2016-06-01

    Hummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices

    Hummingbird Med is recalling Hummi Micro Draw Blood Transfer Devices because the Y connector may separate from the cannula hub during use.

    Product
    ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1763-2016·2016-06-01

    American Surgical Tonsil Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling tonsil sponges due to packaging defects that compromise sterility. The recall covers four boxes distributed worldwide.

    Product
    American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2016·2016-06-01

    AngioVac Circuit Recall Due to Potential Endotoxin Levels

    Angiodynamics is recalling Vortex MEDICAL AngioVac Circuits because they may contain endotoxin levels exceeding regulatory limits.

    Product
    Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2016·2016-06-01

    Draeger D-Vapor Anesthesia Vaporizers Recalled for Anesthetic Agent Release

    Draeger Medical is recalling D-Vapor and D-Vapor 3000 anesthesia vaporizers because they may release desflurane during filling, posing an eye irritation risk.

    Product
    Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2016·2016-06-01

    GE Healthcare Discovery IGS 740 Systems Recalled for Image Loss

    GE Medical Systems is recalling 25 Discovery IGS 740 systems due to potential non-recoverable loss of image acquisition during procedures.

    Product
    GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2016·2016-06-01

    RTI Surgical Recalls Streamline OCT Spinal Fixation Instruments

    RTI Surgical is recalling 17 Streamline OCT Crosslink Counter Torque Sleeves because a defect may obstruct the cannula, potentially causing driver slippage and patient injury.

    Product
    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V393000·2016-06-01

    Volvo Recalls 2017 VNL Trucks Due to Engine Stall Risk

    Volvo Trucks North America is recalling 136 model year 2017 VNL trucks because an engine control module defect may cause an unexpected engine stall, increasing crash risk.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 39 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 16 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1395-2016·2016-06-01

    Kool-Aid Jammers Cherry Recalled for Possible Glass Fragments

    Kraft Heinz Foods is recalling Kool-Aid Jammers Cherry due to the possible presence of glass fragments.

    Product
    Kool-Aid Jammers Cherry packaged in a red box with white lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1807-2016·2016-06-01

    American Surgical Policot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.

    Product
    American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 97 boxes of Delicot 5 mm x 13 mm sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1403-2016·2016-06-01

    Simply Delicious Recalls Lemon Poppyseed Oat Bars Due to Mispackaging

    Simply Delicious is recalling Lemon Poppyseed Oat Bars because they were mispackaged with Coconut bars. The recall covers 142 cases distributed nationwide.

    Product
    Bobo's Oat Bars, Gluten Free, Lemon Poppyseed, Net Weight 3 oz (85g), packaged in clear plastic, 12 bars per sleeve, also sold as individual units. Manufactured by Simply Delicious, Inc.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 21 boxes of Delicot non-xray sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2016·2016-06-01

    American Surgical Americot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Americot White sponges because defective packaging may compromise sterility. The recall covers 35 boxes distributed worldwide.

    Product
    American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1773-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 27 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 27 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1706-2016·2016-06-01

    GE Healthcare Discovery IGS 730 Recalled for Potential Image Loss

    GE Medical Systems is recalling 54 Discovery IGS 730 systems due to a risk of non-recoverable loss of image acquisition during procedures.

    Product
    GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2016·2016-06-01

    American Surgical Recalls Americot Blue Sponges Due to Packaging Defects

    American Surgical Company is recalling 37 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2016·2016-06-01

    American Surgical Company Recalls Neurosurgical Sponges Due to Packaging Defect

    American Surgical Company is recalling 16 boxes of Mass Eye & Ear Finger Cot Nasal sponges because defective packaging compromises sterility.

    Product
    Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling 39 boxes of Uniqcot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1383-2016·2016-06-01

    Mighty Leaf Organic Ginger Peach Iced Tea Recalled for Salmonella Risk

    Mighty Leaf Tea is recalling Organic Ginger Peach Iced Tea due to potential Salmonella contamination identified by a supplier.

    Product
    Mighty Leaf Tea Company Organic Ginger Peach Iced Tea; 100/1 oz. per case Item number 60001. UPC: 00656252600019
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-1728-2016·2016-06-01

    American Surgical Recalls Sponges Due to Packaging Sterility Defect

    American Surgical Company is recalling 103 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2016·2016-06-01

    B. Braun Recalls WHIN Infusion Sets Due to Needle Protrusion Risk

    B. Braun Medical is recalling WHIN Infusion Sets because the Huber needle tip may protrude from the needle guard, posing a safety risk to patients.

    Product
    WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1774-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Defects Compromising Sterility

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 38 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

    American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 24 boxes distributed worldwide.

    Product
    American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall affects worldwide distribution.

    Product
    American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1771-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 209 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1321-2016·2016-06-01

    AA USA Trading Ginger Slices Recalled for Undeclared Sulfites

    AA USA Trading Inc. is recalling 8-ounce packages of Ginger Slices because they contain undeclared sulfites. The product was distributed in New York and New Jersey.

    Product
    AA USA Trading Inc. Ginger Slice Net Wt: 8 oz., AA USA Trading Inc. 47 Reid St. South River, NJ 08882
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1825-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1789-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Delicot sponges because defective packaging may compromise sterility. The recall covers 343 boxes distributed worldwide.

    Product
    American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

    American Surgical Company is recalling 15 boxes of Americot Blue sponges because defective packaging compromises sterility.

    Product
    American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 33 boxes of Ultracot sponges because defective packaging may compromise sterility. The affected products were distributed worldwide.

    Product
    American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 22 boxes of Americot Blue sponges because defective packaging may compromise sterility.

    Product
    American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1828-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Implants Due to Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1765-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers three boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 165 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1394-2016·2016-06-01

    Kool-Aid Jammers Grape Recalled for Possible Glass Fragments

    Kraft Heinz Foods is recalling Kool-Aid Jammers Grape due to the possible presence of glass fragments. Consumers should stop using the product.

    Product
    Kool-Aid Jammers Grape packaged in a purple and red box with white lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1711-2016·2016-06-01

    Limacorporate SMR Glenosphere Impactor/Extractor Recalled for Intra-operative Breakage

    Limacorporate is recalling 314 SMR glenosphere impactor/extractor units due to reports of breakage during surgery. The devices were distributed in the US and Australia.

    Product
    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 11 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2016·2016-06-01

    American Surgical Policot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Policot sponges because defective packaging compromises sterility. The products were distributed worldwide.

    Product
    American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 41 boxes of Ultracot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1392-2016·2016-06-01

    Kraft Heinz Recalls CapriSun Tropical Punch Due to Possible Glass Fragments

    Kraft Heinz is recalling CapriSun tropical punch due to the possible presence of glass fragments. Consumers should stop using the product and contact the company for a refund.

    Product
    CapriSun tropical punch packaged in a blue and white box with pictures of fruit and white and black lettering.
    Category
    Food
    Distribution
    0 states

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