The Recall Desk

Archive

October 2014 recalls

501 recalls were announced in October 2014.

What the numbers show

Critical
33
Severe
108
High
200
Moderate
147
Low
13

Of the 501 recalls this month scored against our rubric, 7% are Critical, 22% are Severe.

201–300 of 501

  • SevereNHTSA·14V652000·2014-10-17

    Keystone Recalls 2014-2015 Dutchmen Travel Trailers Due to Electrical Fire Risk

    Keystone RV Company is recalling 2014-2015 Dutchmen Aerolite and Denali travel trailers because a 12V breaker may not be connected to the protected terminal, posing a fire risk.

    Product
    DUTCHMEN — DUTCHMEN, KEYSTONE AEROLITE, DUTCHMEN DENALI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V653000·2014-10-17

    Great Dane Recalls 2015 Converter Dollies Due to Brake Valve Defect

    Great Dane Trailers is recalling 125 model year 2015 Converter Dollies because a brake valve issue may cause brake drag, leading to overheating, fire, or wheel detachment.

    Product
    GREAT DANE — GREAT DANE CONVERTER DOLLY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V650000·2014-10-17

    BMW Recalls 2015 X5 Vehicles for Rear Seat Belt Welding Defect

    BMW is recalling 2015 X5 vehicles with optional rear comfort seats because the left rear seat belt attachment may not be sufficiently welded, increasing injury risk in a crash.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V654000·2014-10-17

    Maserati Recalls 2014-2015 Models Due to Fuel Hose Fire Risk

    Maserati is recalling 2014-2015 Quattroporte and Ghibli vehicles because improperly crimped fuel delivery hoses may leak fuel and cause a fire.

    Product
    MASERATI — MASERATI QUATTROPORTE, GHIBLI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V649000·2014-10-17

    Ford Recalls 2015 Mustangs for Passenger Air Bag Sensor Defect

    Ford is recalling 2015 Mustangs because the passenger seat sensor may misclassify occupant size, potentially causing improper air bag deployment in a crash.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V651000·2014-10-17

    Turtle Top Transit Buses Recalled for Wheelchair Lift Platform Cracking Risk

    Turtle Top is recalling specific transit buses equipped with Ricon wheelchair lifts because the platform side plates may crack, posing an injury risk to operators.

    Product
    TURTLE TOP — TURTLE TOP VANTERRA, ODYSSEY XL, ODYSSEY LT, ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·15706·2014-10-16

    Honda Recalls 2014 Pioneer 700 Off-Highway Vehicles Due to Fire Hazard

    American Honda is recalling about 15,400 2014 Honda Pioneer 700 recreational off-highway vehicles because debris on the skid plate can ignite from the exhaust system.

    Product
    Recreational off-highway vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·070-2014·2014-10-16

    Shop Packaging Recalls Chicken Wings for Undeclared Soy Allergen

    Shop Packaging LLC is recalling 115,505 pounds of chicken wings due to misbranding and an undeclared soy allergen. The products were shipped to New York.

    Product
    Shop Packaging, LLC — Massachusetts Firm Recalls Chicken Products Due to Possible Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighCPSC·15008·2014-10-16

    Sanus Simplicity SLF5 Wall Mounts Recalled Due to Impact Hazard

    Milestone AV Technologies is recalling Sanus Simplicity SLF5 wall mounts because a nut can loosen, causing the TV to detach and pose an impact hazard.

    Product
    Sanus Simplicity SLF5 flat screen television wall mounts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V648000·2014-10-16

    BMW Recalls 2015 X3 and X4 Vehicles for Rearview Mirror Defect

    BMW is recalling 2015 X3 and X4 vehicles because the driver's side exterior rearview mirror may not meet US safety standards, increasing crash risk.

    Product
    BMW — BMW X3, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15707·2014-10-16

    Briggs & Stratton Recalls Snapper Riding Mowers Due to Brake Failure Risk

    Briggs & Stratton is recalling about 8,500 Snapper rear engine riding mowers because a weld on the drive axle can fail, causing loss of brake control.

    Product
    Brigg & Stratton Snapper Rear Engine Riding Mower
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0006-2015·2014-10-15

    Expo Fresh Recalls Roma Tomatoes Due to Salmonella Risk

    Expo Fresh L.L.C is recalling 10,072 boxes of Roma Tomatoes due to potential Salmonella contamination. The product was distributed nationwide.

    Product
    Roma Tomatoes, 25lbs. case
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0011-2015·2014-10-15

    Unique Pharmaceutical Recalls N-Acetyl Cysteine Vials Due to Non-Sterility

    Unique Pharmaceutical, Ltd is recalling one lot of N-Acetyl Cysteine 20% vials because testing revealed the presence of Herbaspirillum huttiense bacteria.

    Product
    N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0019-2015·2014-10-15

    Mars Recalls Twix Unwrapped Bites for Undeclared Peanuts and Eggs

    Mars Chocolate North America is recalling Twix Unwrapped Bites due to undeclared peanuts and eggs. The recall covers 13,560 pouches distributed nationwide.

    Product
    Twix Unwrapped Bites 7.0 oz. distributed by Mars chocolate na, llc Hackettstown, NJ 07840-1503 USA UPC 040000484325 contained in a Metallized-golden stand up pouch (SUP) package 5 pouches per carton, 2 cartons per case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0002-2015·2014-10-15

    Starway Inc. Recalls Peony Mark Roasted and Salted Pumpkin Seeds

    Starway Inc. is recalling Peony Mark brand roasted and salted pumpkin seeds due to undeclared sulfites. The product was distributed in New York, New Jersey, Massachusetts, and Michigan.

    Product
    PEONY MARK brand ROASTED AND SALTED PUMPKIN SEED, NET WT. 12 oz. (340 gm), Barcode 6 932692 225765, PRODUCT OF CHINA --- PACKED FOR: STARWAY INC 137 GRATTAN STREET, BROOKLYN, NEW YORK 11237 --- NUTRITION FACTS: Serving Size 1 oz., Servings per container 12
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0001-2015·2014-10-15

    Whole Foods 365 Mini Butter Croissants Recalled for Undeclared Egg Allergen

    Whole Foods Market is recalling 365 brand Mini Butter Croissants because they contain egg, which is not listed on the label.

    Product
    Mini Butter Croissant 6 Pack Ingredients: Wheat Flour (unbleached enriched wheat flour, malted barley flour, niacin, Iron, thiamin mononitrate, riboflavin, ascorbic acid, folic acid), Butter, Water, Sugar, Non Fat Dry Milk, Yeast, Salt, Dough Conditioner (dextrose, wheat flour,
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·14V647000·2014-10-15

    Lexus Fuel Leak Recall for 2006-2011 Models

    Toyota is recalling 2006-2011 Lexus vehicles because fuel may leak from the pressure sensor, increasing fire risk.

    Product
    LEXUS — LEXUS LS460, LS460L, IS F, IS 350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0009-2015·2014-10-15

    Mylan Recalls Metoprolol Succinate Tablets Due to Foreign Object Presence

    Mylan Pharmaceuticals is recalling 15,966 bottles of Metoprolol Succinate Extended-release Tablets 50mg because a pharmacist reported finding a rogue tablet of different size and markings in a bottle.

    Product
    Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0058-2015·2014-10-15

    Biomet Recalls Mamba Disposable Nitinol Needles Due to Breakage Risk

    Biomet is recalling 164 Mamba Disposable Nitinol Needles because high friction may cause the needles to break during use.

    Product
    Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0005-2015·2014-10-15

    Publix Jalapeno Bagels Recalled for Potential Glass and Stone Contamination

    Publix Super Markets is recalling Jalapeno Bagels sold in Alabama, Florida, Georgia, and South Carolina because they may contain pieces of glass and small stones.

    Product
    Publix brand Jalapeno Bagels, sold in self service bins and counter sales.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0003-2015·2014-10-15

    Brilliant Cake Biscuits Recalled for Undeclared Eggs and Unapproved Colors

    Domega NY International Co Ltd is recalling Brilliant Cake with Filling Milk (Biscuits) due to undeclared eggs and unapproved food colors.

    Product
    Brilliant Cake with Filling Milk (Biscuits), NET WT 13.9 oz (396 g), UPC 6 908166 500140, Product of China --- The product is packed in a plastic wrapped package.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0018-2015·2014-10-15

    SABA ACE Appetite Control Energy Recalled for DMAA Presence

    AMS Health Sciences is recalling SABA ACE products manufactured before September 2013 due to the presence of DMAA.

    Product
    saba; ACE; Appetite Control Energy; 052234; 07/2015; Distributed by Saba; 711 NE 39th Street, Oklahoma City, OK 73105
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0007-2015·2014-10-15

    Frozen Jalapeno Bagels Recalled Due to Glass and Stone Contamination

    Wholesome Harvest Baking is recalling frozen jalapeno bagels because of reports of glass pieces and stones in the product.

    Product
    Frozen jalapeno bagels sold under the Maple Leaf Bakery brand in three different sizes: 3 oz. (64 bagels/case), 4 oz. (78 bagels/case), and 4.5 oz. (72 bagels/case)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0006-2015·2014-10-15

    Janssen Recalls Xarelto Tablets Due to Microbial Contamination

    Janssen Ortho L.L.C. is recalling 13,500 bottles of Xarelto (rivaroxaban) 15 mg tablets due to confirmed microbial contamination in a sales sample.

    Product
    Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0007-2015·2014-10-15

    Zydus Recalls Atenolol Tablets Due to Superpotent Drug Complaint

    Zydus Pharmaceuticals is recalling 5,400 bottles of Atenolol 25 mg tablets nationwide after a pharmacist reported that several tablets appeared noticeably thicker.

    Product
    ATENOLOL — ATENOLOL (ATENOLOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0018-2015·2014-10-15

    Cardinal Health Prefilled Buffered 10% Formalin Recalled for Concentration Issues

    Richard-Allan Scientific Company is recalling Cardinal Health Prefilled Buffered 10% Formalin because the formalin concentration may be outside specifications.

    Product
    Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0029-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intraven
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0031-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0061-2015·2014-10-15

    DePuy Charnley Pin Retractor and Handle Set Recalled for Component Breakage

    DePuy Orthopaedics is recalling 65 units of the Charnley Pin Retractor and Handle Set because the small extraction peg is breaking from the pin.

    Product
    Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0028-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Defects

    Navilyst Medical is recalling BioFlo PICC Kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the ad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2015·2014-10-15

    Bio-Detek Recalls ZOLL Pro-padz Sterile Adult Electrodes Due to Sterility Concerns

    Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 41 single units distributed worldwide.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed thr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0034-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling 51 PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE --- Indicated short or long-term peripheral access to the central venous system for intravenous therapy, including but not lim
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2015·2014-10-15

    Nemschoff Serenity Treatment Chairs Recalled for Potential Elevated Temperatures

    Nemschoff Chairs, Inc. is recalling Serenity Treatment Chairs due to potential elevated temperatures in the seat and back lumbar areas.

    Product
    Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15007·2014-10-15

    Toys R Us Recalls Toy Toaster Sets Due to Choking Hazard

    Toys R Us is recalling Just Like Home toy toaster sets because the plastic toast can break into sharp pieces, posing a choking hazard.

    Product
    Just Like Home Toy Toaster Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2015·2014-10-15

    Biomet Recalls Green Mamba Suture Passers Due to Needle Breakage Risk

    Biomet, Inc. is recalling 12 units of Green Mamba Suture Passers because high friction may cause the needle to break during use.

    Product
    Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0004-2015·2014-10-15

    Maruto C Wheat Cake Recalled for Missing Soy Allergen Labeling

    Ikko International Trading LLC is voluntarily recalling Maruto 'C' Wheat Cakes because the packaging omitted soy lecithin as an ingredient and allergen warning.

    Product
    Wheat Cake (Maruto "C" Cake), 6.3 ounces (180g), individually packaged in gold foil pouches and sold under the Maruto Brand. Sold at retail locations in display cases containing 8 bars per display case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0038-2015·2014-10-15

    DePuy Orthopaedics Recalls RECLAIM Distal Reamer Extension Devices

    DePuy Orthopaedics is recalling 875 units of RECLAIM Distal Reamer Extension devices because the tabs may break and leave fragments in the patient.

    Product
    RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0054-2015·2014-10-15

    ZOLL Pro-padz Sterile Adult Electrodes Recalled Due to Sterility Concerns

    Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because product sterility is not assured. The recall affects 193 cases distributed worldwide.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0014-2015·2014-10-15

    Mars Recalls M&M's Chocolate Candies Due to Undeclared Peanuts

    Mars Chocolate North America is recalling specific M&M's products because they contain undeclared peanuts, a major food allergen.

    Product
    Mars Chocolate North America Milk Chocolate M & M's Net Wt. 3.40 oz packed in a brown, 3 inch x 6.5 inch cardboard box 12 Theater boxes per case Distributed by Mars Snackfoods US LLC., Hackettstown, NJ 07840-1503 UPC 40000294764
    Category
    Food
    Distribution
    37 states
  • HighFDA (Devices)·Z-0056-2015·2014-10-15

    Biomet Black Mamba Suture Passer Recalled Due to Needle Breakage Risk

    Biomet, Inc. is recalling 15 units of Black Mamba Suture Passers because high friction may cause the needle to break during use.

    Product
    Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0052-2015·2014-10-15

    Zoll Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns

    Bio-Detek is recalling 237 cases of Zoll Pro-padz Sterile Multi-Function Electrodes because product sterility is not assured. The affected lots were distributed worldwide.

    Product
    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0042-2015·2014-10-15

    McKesson Cardiology Hemo Software Recall for Hemoglobin Calculation Error

    McKesson Information Solutions LLC is recalling 272 McKesson Cardiology Hemo devices because a software error incorrectly converts hemoglobin values used in formula calculations.

    Product
    McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues

    Navilyst Medical is recalling specific BioFlo PICC kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0053-2015·2014-10-15

    ZOLL Pro-padz Sterile Electrodes Recalled Due to Sterility Concerns

    Bio-Detek is recalling ZOLL Pro-padz Sterile Multi-Function Electrodes because product sterility is not assured. The recall affects lots 1614 and 1814 distributed worldwide.

    Product
    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intrave
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2015·2014-10-15

    Richard Wolf Recalls Hulka Clip Tubal Occluding Device Lot 51000232

    Richard Wolf Medical Instruments is recalling Hulka Clip Tubal Occluding Devices (Lot 51000232) due to a biocompatibility test discrepancy found in a subsequent lot.

    Product
    The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0032-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits with Compromised Sterility

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2015·2014-10-15

    ArjoHuntleigh Contoura C1000 and C1080 Bariatric Beds Recalled for Entrapment Risk

    Arjo Hospital Equipment AB is recalling 1,695 Contoura C1000 and C1080 bariatric beds worldwide due to a low but existing risk of patient entrapment for individuals with a BMI under 40.

    Product
    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2015·2014-10-15

    Biomedix SELEC-3 I.V. Administration Set Recalled Due to Adhesive Failure

    Biomedix is recalling SELEC-3 I.V. Administration Sets because insufficient glue application caused the sets to fail.

    Product
    Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0059-2015·2014-10-15

    Sterilmed Recalls Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters

    Sterilmed is recalling 22 reprocessed diagnostic ultrasound catheters because they were incorrectly processed. The affected units were distributed in Washington and California.

    Product
    Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0005-2015·2014-10-15

    Mylan Amiodarone Hydrochloride Injection Recalled for Temperature Abuse

    Mylan Institutional LLC is recalling Amiodarone HCl Injection due to inadvertent refrigeration during distribution. McKesson distributed the affected vials to facilities in WA, OR, and MT.

    Product
    AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0014-2015·2014-10-15

    Richard-Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Concentration Issues

    Richard-Allan Scientific is recalling 10% Neutral Buffered Formalin because the concentration may be outside specifications. The product is used to fixate tissue for histological examination.

    Product
    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0017-2015·2014-10-15

    Richard-Allan Scientific Recalls Specimen Transportation System Due to Concentration Issues

    Richard-Allan Scientific is recalling 264 cases of its Specimen Transportation System because the NBF concentration may be outside specifications.

    Product
    Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2015·2014-10-15

    Richard-Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Concentration Issues

    Richard-Allan Scientific is recalling 199 cases of 10% Neutral Buffered Formalin because the chemical concentration may be outside of desired specifications.

    Product
    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Wound Therapy Canisters

    Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters due to visible deformation of the inlet port on the canister lid.

    Product
    RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0008-2015·2014-10-15

    Hostess Frosted Bagged Donettes Recalled for Potential Mold Growth

    Hostess Brands LLC is recalling Frosted Bagged Donettes due to potential mold growth caused by higher-than-average moisture content.

    Product
    Hostess Frosted Bagged Donettes, 11.25 oz
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0017-2015·2014-10-15

    Mothers' Milk Bank of Montana Recalls Unpasteurized Human Milk

    Mothers' Milk Bank of Montana is recalling frozen unpasteurized human milk because a donor received live vaccines after delivery.

    Product
    Frozen Unpasteurized Human Milk in glass bottle. No labeling provided
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0008-2015·2014-10-15

    Astellas Recalls Tarceva Tablets Due to Failed Dissolution Specifications

    Astellas Pharma US Inc is recalling 9,236 bottles of Tarceva (erlotinib) 150 mg tablets because they failed routine stability testing for dissolution.

    Product
    Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues

    Navilyst Medical is recalling BioFlo PICC kits because included BD syringes had open seals, potentially affecting sterility.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformation

    Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters because the inlet port on the lid may be deformed.

    Product
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0013-2015·2014-10-15

    Hostess Recalls Frozen Donettes Due to Potential Mold Growth

    Hostess Brands LLC is recalling specific lots of frozen Donettes due to potential mold growth caused by higher-than-average moisture content.

    Product
    Hostess Powdered Single-Serve Donettes- FROZEN ONLY, 3 oz., 6 ct.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0015-2015·2014-10-15

    NatureBox Cranberry Macaroon Granola Recalled for Incorrect Back Label

    NatureBox is recalling 1,262 pouches of Cranberry Macaroon Granola because the back label incorrectly displays ingredients and nutrition for Cherry Berry Granola.

    Product
    naturebox cranberry macaroon granola net wt. 3.75 oz (106g) naturebox.com Back label incorrectly has nutrition and ingredients for cherry berry granola labeled in part as: Ingredients: Whole grain oats, brown sugar, dried cranberries (cranberries, sugar, sunflower oil) almo
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0011-2015·2014-10-15

    Hostess Frosted Bagged Donettes Recalled for Potential Mold Growth

    Hostess Brands LLC is recalling specific frozen donettes due to potential mold growth caused by higher-than-average moisture content.

    Product
    Hostess Frosted Bagged Donettes- FROZEN ONLY, 11.25 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0012-2015·2014-10-15

    Hostess Recalls Frozen Donettes Due to Potential Mold Growth

    Hostess Brands LLC is recalling specific lots of frozen Donettes because laboratory analysis found higher-than-average moisture content, creating a potential for mold growth.

    Product
    Hostess Powdered Bagged Donettes- FROZEN ONLY, 10.5 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0010-2015·2014-10-15

    VistaPharm Recalls Metoclopramide Oral Solution Due to Leaking Containers

    VistaPharm is recalling 322,650 cups of Metoclopramide Oral Solution because the containers leak when inverted.

    Product
    METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended for short or long-term peripheral access to the central venous system for intraven
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformed Inlet Ports

    Smith & Nephew is recalling RENASYS EZ and EZ Plus 800 mL canisters with deformed inlet ports on the lid. The defect may affect the collection of wound exudate during negative pressure wound therapy.

    Product
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0016-2015·2014-10-15

    Mothers' Milk Bank of Montana Recalls Frozen Pasteurized Human Milk

    Mothers' Milk Bank of Montana is recalling 12 bottles of frozen pasteurized human milk because a donor received live vaccines after delivery.

    Product
    Frozen Pasteurized Human Milk in glass bottles. Label contains lot code followed by expiration date (month day year) and the description of the product which states Mature Milk. There is a Mothers' Milk Bank logo
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0035-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Issues

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0010-2015·2014-10-15

    Hostess Powdered Donettes Recalled for Potential Mold Growth

    Hostess Brands LLC is recalling specific lots of Powdered Single-Serve Donettes due to higher-than-average moisture content that may allow mold growth.

    Product
    Hostess Powdered Single-Serve Donettes, 3 oz., 6 ct.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0009-2015·2014-10-15

    Hostess Powdered Bagged Donettes Recalled for Potential Mold Growth

    Hostess Brands LLC is recalling 17,330 units of Powdered Bagged Donettes due to potential mold growth caused by higher-than-average moisture content.

    Product
    Hostess Powdered Bagged Donettes, 10.5 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0062-2015·2014-10-15

    Orthohelix MaxLock Reamer Recalled for Incorrect Laser-Etched Sizing

    Orthohelix Surgical Designs is recalling 38 MaxLock Extreme Mod-Foot Concave Reamers because incorrect sizing was laser-etched on the devices.

    Product
    MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0026-2015·2014-10-15

    Navilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues

    Navilyst Medical is recalling specific BioFlo PICC kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, includin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0021-2015·2014-10-15

    Biomet Compress Face Reamer Recalled for Missing Helix Angle

    Biomet, Inc. is recalling four Compress Face Reamer units because they were missing the required 4x21 degree helix angle.

    Product
    Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0024-2015·2014-10-15

    Siemens Recalls Dimension Vista Mass CKMB Isoenzyme Calibrator Due to Drift

    Siemens Healthcare Diagnostics is recalling Dimension Vista Mass CKMB Isoenzyme Calibrators because routine stability monitoring showed drift exceeding acceptance criteria.

    Product
    Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0013-2015·2014-10-15

    Richard-Allan Scientific Recalls Specimen Transportation System Due to Concentration Issues

    Richard-Allan Scientific is recalling 285 cases of its Specimen Transportation System because the NBF concentrations may not meet specifications.

    Product
    Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0015-2015·2014-10-15

    Richard-Allan Scientific Recalls Bio-Tite Specimen Containers Due to Concentration Issues

    Richard-Allan Scientific is recalling Bio-Tite Specimen Containers because the NBF concentration may be outside specifications.

    Product
    Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0014-2015·2014-10-15

    Bracco Recalls E-Z-GAS Antacid Due to Subpotent Drug Levels

    Bracco Diagnostic Inc is recalling E-Z-GAS antacid packets because routine stability testing found the drug to be subpotent.

    Product
    E-Z-GAS — E-Z-GAS (ANTACID/ANTIFLATULENT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0013-2015·2014-10-15

    Gilead Recalls Truvada Tablets Due to Silicone Rubber Particulates

    Gilead Sciences is recalling Truvada tablets because they contain small red silicone rubber particulates. The recall affects 10,317 bottles distributed nationwide.

    Product
    TRUVADA — TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0012-2015·2014-10-15

    Richard-Allan Scientific Recalls Protocol 10% NBF Tissue Fixative

    Richard-Allan Scientific is recalling 175 cases of Protocol 10% NBF tissue fixative because the concentration may be outside specifications.

    Product
    Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·069-2014·2014-10-14

    Italian Style Wedding Soup Recalled for Undeclared Soy and Egg Allergens

    Fresh Food Manufacturing is recalling 1,008 pounds of Italian Style Wedding Soup because the label failed to declare soy and egg allergens.

    Product
    Fresh Food Manufacturing Company — Pennsylvania Firm Recalls Italian Style Wedding Soup Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·14V646000·2014-10-14

    Vermeer Recalls 2014 TR620 Trailers Due to Hitch Mount Defect

    Vermeer is recalling 2014 TR620 Trommel trailers because an incorrect material in the pintle hitch mount may allow bolts to loosen, increasing crash risk.

    Product
    VERMEER — VERMEER TR620
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V643000·2014-10-14

    Chrysler Recalls 2014 Dodge Durango and Jeep Grand Cherokee for Airbag Fault

    Chrysler is recalling 2014 Dodge Durango and Jeep Grand Cherokee vehicles because a module fault may disable airbags and seat belt pretensioners, increasing injury risk in crashes.

    Product
    DODGE — DODGE, JEEP DURANGO, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·067-2014-EXP·2014-10-13

    Galant Food Company Recalls Additional Beef Piroshki Due to Processing Flaw

    Galant Food Company is recalling an additional 130 pounds of beef piroshki because the meat filling did not reach the required cooking temperature.

    Product
    Galant Food Co — California Firm Expands Recall of Beef Products Due To Possible Processing Flaw
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V638000·2014-10-10

    Strick Dry Freight Van Trailers Recalled for Rear Impact Guard Defect

    Strick Trailers is recalling 2009-2015 Dry Freight Van Trailers because rear impact guards do not meet federal safety standards, increasing injury risk in crashes.

    Product
    STRICK — STRICK DRY FREIGHT VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V642000·2014-10-10

    Wheeled Coach Recalls Ambulances Due to Suspension Tank Mount Failure Risk

    Wheeled Coach is recalling certain 2013-2015 ambulances because a suspension fluid tank mount may fail, causing the tank to separate and create a road hazard.

    Product
    WHEELED COACH — WHEELED COACH TYPE III AMBULANCE, TYPE I AMBULANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V641000·2014-10-10

    Mobility Works Recalls Ford Vans with Cracking Wheelchair Lifts

    Mobility Works is recalling 834 Ford E-Series vans modified with Ricon wheelchair lifts. The platform side plates may crack, causing the lift to fall and injure the operator.

    Product
    FORD — FORD, MOBILITY WORKS E150, E250, E350, fORD E-150
    Category
    Vehicle
    Distribution
    Distributed nationwide

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