The Recall Desk

Archive

March 2014 recalls

554 recalls were announced in March 2014.

What the numbers show

Critical
40
Severe
147
High
238
Moderate
117
Low
12

Of the 554 recalls this month scored against our rubric, 7% are Critical, 27% are Severe.

101–200 of 554

  • ModerateFDA (Devices)·Z-1258-2014·2014-03-26

    Zimmer Recalls Apollo Knee System Patella Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of Apollo Knee System patella components due to discoloration caused by premature oxidation during storage.

    Product
    Apollo" Knee System: APOLLO PATELLA SZ0 28MM R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1242-2014·2014-03-26

    Biomet Recalls Intramedullary Bone Saw CAM Assembly Due to Labeling Error

    Biomet, Inc. is recalling specific lots of the Intramedullary Bone Saw CAM Assembly because the Saw Blade Assembly was incorrectly identified as a CAM Assembly.

    Product
    Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1166-2014·2014-03-26

    Pfizer Recalls Advil PM Caplets Due to Low Diphenhydramine Levels

    Pfizer is recalling 70,704 bottles of Advil PM caplets nationwide because the diphenhydramine citrate content was found to be out of specification.

    Product
    ADVIL PM — ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1233-2014·2014-03-26

    Biomet Recalls Endobon Xenograft Granules Due to Incorrect Batch Labels

    Biomet 3i, LLC is recalling 704 units of Endobon Xenograft Granules 0.5 ML because individual pieces may have incorrect labels with the wrong batch number.

    Product
    ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
    Category
    Medical Device
    Distribution
    13 states
  • LowFDA (Drugs)·D-1167-2014·2014-03-26

    McKesson Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failure

    McKesson Packaging Services is recalling 1,557 boxes of Venlafaxine Hydrochloride Extended Release Capsules, 150 mg, due to out-of-specification dissolution results.

    Product
    Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V143000·2014-03-25

    NABI Transit Buses Recalled for CNG Fuel Cylinder Interference Risk

    NABI is recalling 2013-2014 transit buses equipped with compressed natural gas systems because a bolt may damage the fuel cylinder, posing a fire risk.

    Product
    NABI — NABI 40LFW, 35LFW, 31LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14140·2014-03-25

    Wal-Mart Recalls Electronic Baby Dolls Due to Burn Hazard

    Wal-Mart is recalling My Sweet Love and My Sweet Baby Cuddle Care dolls because the internal circuit board can overheat, posing a burn risk to consumers.

    Product
    My Sweet Love / My Sweet Baby Cuddle Care Baby Doll
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E016000·2014-03-25

    Muncie PTO Pressure Switch Recall for Ford Super Duty Chassis

    Muncie Power Products is recalling PTO Assembly Pressure Switches used in 2009-2014 Ford Super Duty chassis. The switches may leak oil, posing a fire risk near the exhaust.

    Product
    ENGINE AND ENGINE COOLING:ENGINE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V141000·2014-03-25

    KZRV Recalls 2014 Sportsmen Trailers Due to Axle Defect

    KZRV is recalling 2014 Sportsmen 290IKSS travel trailers because the axles may not support the trailer's weight, increasing crash risk.

    Product
    SPORTSMEN — SPORTSMEN 290IKSS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V145000·2014-03-25

    Peterbilt Trucks Recalled for Improper Front Brake Linings

    PACCAR is recalling 2008-2013 Peterbilt trucks because front brake linings are not rated for the specific axle and tire configuration, potentially increasing braking distance.

    Product
    PETERBILT — PETERBILT 388, 389, 367, 365
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14138·2014-03-25

    Centex Homes Recalls SolarSave Roof Panels Due to Fire Hazard

    Centex Homes is recalling SolarSave roof panels installed on new homes due to a fire hazard. Two roof fires have been reported, with no injuries.

    Product
    SolarSave® roof panels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V138000·2014-03-25

    Nissan and Infiniti Recall Vehicles Due to Passenger Airbag Software Defect

    Nissan is recalling specific 2013-2014 models because software may incorrectly classify an occupied passenger seat as empty, potentially deactivating the airbag.

    Product
    INFINITI — INFINITI, NISSAN JX35, QX60, Q50, LEAF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V139000·2014-03-24

    Volvo Recalls VNL and VNM Trucks Due to Intake Manifold Defect

    Volvo is recalling 2013-2015 VNL and 2013-2014 VNM trucks because condensation in the intake manifold may freeze, causing sensor issues that increase fire risk.

    Product
    VOLVO — VOLVO VNL, VNM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V137000·2014-03-24

    Mack Trucks Recalling 2010-2015 Models Due to Fire Risk

    Mack Trucks is recalling certain 2010-2015 models because condensation in the intake manifold may freeze, causing sensor issues that could lead to vehicle fires or burn injuries.

    Product
    MACK — MACK MRU, LEU, PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V090000·2014-03-24

    Porsche Recalls 2014 911 GT3 Vehicles Due to Engine Fire Risk

    Porsche is recalling 209 model year 2014 911 GT3 vehicles because a piston connecting rod may come loose, potentially causing an engine fire.

    Product
    PORSCHE — PORSCHE 911 GT3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V136000·2014-03-21

    Keystone Recalls Fifth Wheel Trailers with Defective Frigidaire Microwaves

    Keystone is recalling specific 2013-2014 fifth wheel trailers because the installed Frigidaire microwaves may start on their own, posing a fire risk.

    Product
    KEYSTONE — KEYSTONE DUTCHMEN VOLTAGE, DUTCHMEN INFINITY, ALPINE, MONTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V134000·2014-03-20

    Crossroads RV Recalls 2014 Trailers Due to Microwave Fire Risk

    Crossroads RV is recalling 2014 Redwood and Rushmore trailers because the installed microwave may start on its own, potentially causing a fire.

    Product
    CROSSROADS — CROSSROADS REDWOOD, RUSHMORE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14725·2014-03-20

    Bedz King Recalls Bunk Beds with Side Ladders Due to Entrapment Hazard

    Bedz King is recalling specific bunk bed models with side ladders because a protruding corner post creates an entrapment hazard. No injuries have been reported.

    Product
    Bedz King Bunk Beds with Side Ladder
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14136·2014-03-20

    Minga Recalls Wooden Flipping Acrobat Toys for Lead Paint Violation

    Minga Fair Trade Imports is recalling wooden flipping acrobat toys because the paint contains excessive levels of lead, which is prohibited under federal law.

    Product
    Wooden flipping acrobat toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1659-2014·2014-03-19

    Pecan Shed Recalls Tiger Fudge Due to Undeclared Allergens

    Pecan Shed is recalling Tiger Fudge because it contains undeclared soy, milk, and peanuts. The product was sold in multiple states and online.

    Product
    Tiger Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1665-2014·2014-03-19

    Pecan Shed Recalls Fudge Due to Undeclared Allergens Soy, Pecans, and Milk

    Pecan Shed is recalling Sucrose Free Chocolate Pecan fudge because it contains undeclared soy, pecans, and milk, posing a risk to allergic consumers.

    Product
    Sucrose Free Chocolate Pecan; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Drugs)·D-1154-2014·2014-03-19

    CTV Best Group Recalls BEST Slim Weight Loss Pills

    CTV Best Group is recalling BEST Slim weight loss pills because they contain the undeclared drug sibutramine, making them unapproved new drugs.

    Product
    BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1630-2014·2014-03-19

    Elite Spice Recalls Chipotle Nut Seasoning Due to Salmonella Risk

    Elite Spice Inc. is recalling 500 lbs of Chipotle Nut Seasoning because it may be contaminated with Salmonella. The product was distributed to nine states.

    Product
    Chipotle Nut Seasoning, Elite Code # 38113A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Drugs)·D-1156-2014·2014-03-19

    FDA Recalls Dextrose Vials Due to Mold Contamination

    Specialty Medicine Compounding Pharmacy is recalling 50% Dextrose vials after mold was found in the product. The recall affects 1,000 vials distributed in Michigan.

    Product
    Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Food)·F-1656-2014·2014-03-19

    Pecan Shed Recalls Turtle Fudge Due to Undeclared Allergens

    Pecan Shed is recalling Special Turtle Fudge because it contains undeclared soy, milk, and pecans. The product was sold in-store and online to customers in nine states and Washington DC.

    Product
    Pecan Shed Special Turtle Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1664-2014·2014-03-19

    Pecan Shed Recalls Divinity with Pecans Fudge for Undeclared Allergens

    Pecan Shed is recalling Divinity with Pecans Fudge because the product contains undeclared soy, milk, and pecans. The fudge was sold in retail stores and online to customers in multiple states.

    Product
    Divinity with Pecans Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1661-2014·2014-03-19

    Pecan Shed Chocolate Mint Fudge Recalled for Undeclared Soy and Milk

    Pecan Shed is recalling Chocolate Mint Fudge due to the presence of undeclared allergens soy and milk.

    Product
    Chocolate Mint Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1645-2014·2014-03-19

    Meijer Pretzel Hamburger Buns Recalled for Undeclared Milk Allergen

    Meijer Distribution is recalling Pretzel Hamburger Buns and Pretzel Demi Rolls because the whey powder ingredient is not identified as milk in the allergen statement.

    Product
    Markets of Meijer Pretzel Hamburger Bun, 4 count, NT.WT. 12.0 oz (0.75 lb), 16 oz ( 1 lb) UPC 412500558-2; Ingredients: Enriched Wheat Flour( Wheat Flour, malted barley flour, niacin.....)water, sugar, canola oil, salt, .. , dough conditioner, whey powder, yeast, dough condit
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1654-2014·2014-03-19

    Pecan Shed Plain Chocolate Fudge Recalled for Undeclared Soy and Milk

    Pecan Shed is recalling Plain Chocolate Fudge because it contains undeclared soy and milk allergens. The product was sold in multiple states and online.

    Product
    Plain Chocolate Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1655-2014·2014-03-19

    Pecan Shed Recalls Butter Pecan Fudge Due to Undeclared Allergens

    Pecan Shed is recalling Butter Pecan Fudge because the product contains undeclared soy, milk, and pecans. The fudge was sold in retail stores and online to customers in multiple states.

    Product
    Butter Pecan Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1629-2014·2014-03-19

    Elite Spice Recalls Jalapeno Nut Seasoning Due to Salmonella Risk

    Elite Spice Inc. is recalling 500 lbs of Jalapeno Nut Seasoning because it may be contaminated with Salmonella. The product was distributed to nine states for further manufacturing.

    Product
    Jalapeno Nut Seasoning, Elite Code # 35076A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1631-2014·2014-03-19

    Elite Spice Recalls Ole Hot Chorizo Seasoning Due to Salmonella Risk

    Elite Spice Inc. is recalling Ole Hot Chorizo Seasoning because it may be contaminated with Salmonella. The product was distributed to nine states.

    Product
    Ole Hot Chorizo Seasoning, Elite Spice # 32581A9, 32 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1660-2014·2014-03-19

    Pecan Shed Recalls Sucrose Free Chocolate Plain Fudge for Undeclared Allergens

    Pecan Shed is recalling Sucrose Free Chocolate Plain Fudge due to the presence of undeclared soy and milk allergens.

    Product
    Sucrose Free Chocolate Plain Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1657-2014·2014-03-19

    Pecan Shed Maple Nut Fudge Recalled for Undeclared Allergens

    Pecan Shed is recalling Maple Nut with Pecans Fudge due to undeclared soy, milk, and pecans. The product was sold in nine states and Washington DC.

    Product
    Maple Nut with Pecans Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1663-2014·2014-03-19

    Pecan Shed Recalls Pumpkin Pie Fudge Due to Undeclared Allergens

    Pecan Shed is recalling Pumpkin Pie with Pecans Fudge because it contains undeclared soy, milk, and pecans. The product was sold in multiple states and online.

    Product
    Pumpkin Pie with Pecans Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1658-2014·2014-03-19

    Pecan Shed Recalls Dark Chocolate Fudge Due to Undeclared Allergens

    Pecan Shed is recalling Dark Chocolate with Pecans Fudge because it contains undeclared soy, milk, and pecans. The product was sold in nine states and Washington DC.

    Product
    Dark Chocolate with Pecans Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1635-2014·2014-03-19

    Global Vitality Recalls Colon Rebuild I Supplements Due to Chloramphenicol Contamination

    Global Vitality is recalling Colon Rebuild I dietary supplements because they may be contaminated with chloramphenicol. The product was made with a raw ingredient previously recalled for the same contaminant.

    Product
    Colon Rebuild I (90 capsules), 2boxes x 240 bottles, 1box x 200 bottles.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·14V130000·2014-03-19

    Autocar Recalls 2014 Xpert Trucks Due to Exhaust Fire Risk

    Autocar is recalling 2014 Xpert trucks because condensation in the intake manifold may freeze, causing elevated exhaust temperatures or flames that increase the risk of vehicle fire or burn injury.

    Product
    AUTOCAR — AUTOCAR XPERT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V132000·2014-03-19

    Autocar Recalls 2008-2014 Trucks Due to Intake Manifold Freeze Risk

    Autocar is recalling 4,192 model year 2008-2014 ACX, WX, and WXLL trucks because condensation in the intake manifold may freeze, potentially causing exhaust flames or vehicle fire.

    Product
    AUTOCAR — AUTOCAR ACX, WXLL, WX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1633-2014·2014-03-19

    Elite Spice Recalls Jalapeno Burger Seasoning Due to Salmonella Risk

    Elite Spice Inc. is recalling 100 lbs of Jalapeno Burger Seasoning because it may be contaminated with Salmonella. The product was distributed to nine states.

    Product
    Jalapeno Burger Seasoning, Elite Spice # 32680B2, 50 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1201-2014·2014-03-19

    Mar Cor Purification Reverse Osmosis Systems Recalled for Fire Risk

    Mar Cor Purification is recalling 130 CWP Reverse Osmosis Systems (Models 101, 102, 104, and 106) due to a potential fire hazard from resistive heating in the pump head assembly.

    Product
    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1653-2014·2014-03-19

    Pecan Shed Recalls Chocolate Pecan Fudge Due to Undeclared Allergens

    Pecan Shed is recalling Chocolate Pecan Fudge because the product contains undeclared soy, milk, and pecans. The fudge was sold in nine states and Washington DC.

    Product
    Chocolate Pecan Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1176-2014·2014-03-19

    Biosense Webster Recalls PentaRay Nav Catheters Due to Tip Separation Risk

    Biosense Webster is recalling PentaRay Nav and PentaRay Nav ECO catheters because the distal tip may separate from the shaft.

    Product
    PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiologica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1640-2014·2014-03-19

    Global Vitality Recalls Total Digestion Supplements Due to Chloramphenicol Contamination

    Global Vitality is recalling Total Digestion dietary supplements because they may be contaminated with chloramphenicol. The product was made with a raw ingredient previously recalled for the same contaminant.

    Product
    Total Digestion, Lot 1635, 4 boxes x 9.92 kg. Lot 1841, 4 boxes x 12 kg, 1 box x 11.24 kg. Lot 2017, 3 boxes x 10 kg, 1 box x 9.32 kg.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1642-2014·2014-03-19

    Global Vitality Recalls Super Digestayme Supplements Due to Chloramphenicol Contamination

    Global Vitality is recalling Super Digestayme dietary supplements because they may be contaminated with chloramphenicol. The products were made with a raw ingredient previously recalled for the same contaminant.

    Product
    Super Digestayme, 200 count, 2 boxes x 72 bottles, 1 box x 55 bottles. 300 count, 4 boxes x 72 bottles, 1 box x 12 bottles.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1666-2014·2014-03-19

    Pecan Shed Recalls Birthday Cake Fudge for Undeclared Soy and Milk Allergens

    Pecan Shed is recalling Birthday Cake Fudge because the product contains undeclared soy and milk allergens. The fudge was sold in retail stores and online to customers in nine states and Washington DC.

    Product
    Birthday Cake Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1662-2014·2014-03-19

    Pecan Shed Recalls Pumpkin Pie Fudge for Undeclared Soy and Milk

    Pecan Shed is recalling Pumpkin Pie Fudge because it contains undeclared soy and milk allergens. The product was sold in multiple states and online.

    Product
    Pumpkin Pie Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***"
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1632-2014·2014-03-19

    Elite Spice Mexican Style Mild Chorizo Recalled for Salmonella Risk

    Elite Spice Inc. is recalling Mexican Style Mild Chorizo due to potential Salmonella contamination. The product was distributed to nine states.

    Product
    Mexican Style Mild Chorizo, Elite Spice # 32582A9, 24 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
    Category
    Food
    Distribution
    10 states
  • SevereNHTSA·14V131000·2014-03-19

    Autocar Recalls Xspotter Vehicles Due to Intake Manifold Sensor Defect

    Autocar is recalling 2010-2014 Xspotter vehicles because condensation in the intake manifold may freeze and interfere with the pressure sensor, potentially causing exhaust flames or fire.

    Product
    AUTOCAR — AUTOCAR XSPOTTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1628-2014·2014-03-19

    Elite Spice Recalls Jalapeno Ground 40 Due to Salmonella Risk

    Elite Spice Inc. is recalling 800 lbs of Jalapeno Ground 40 due to potential Salmonella contamination. The product was distributed to nine states.

    Product
    Jalapeno Ground 40, Elite Spice Code #JP9520, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1172-2014·2014-03-19

    Accumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Erroneous Results

    Accumetrics is recalling VerifyNow IIb/IIIa test kits because they may report erroneous low platelet aggregation unit results, potentially affecting clinical decisions.

    Product
    VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2014·2014-03-19

    GE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues

    GE Healthcare is recalling CARESCAPE Monitor B650 and B850 units due to potential safety issues with Non-Invasive Blood Pressure and Bed to Bed functions.

    Product
    GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2014·2014-03-19

    BioMerieux PREVI Isola System Recalled for Potential False Negative Results

    BioMerieux is recalling 471 PREVI Isola Systems because they may fail to dispense urine samples, potentially leading to false negative growth results.

    Product
    bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1207-2014·2014-03-19

    DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defect

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.

    Product
    REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2014·2014-03-19

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Shock Delivery Failure

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may display a Red X during automated tests, indicating a failure that could prevent the delivery of a shock or pacing.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2014·2014-03-19

    DePuy S-ROM Noiles Rotating Hinge Femur Recalled for Sterile Barrier Defects

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.

    Product
    REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14135·2014-03-19

    Ganz Recalls Grumpy Cat Stuffed Animals Due to Choking Hazard

    Ganz is recalling three styles of Grumpy Cat plush toys because their eyes can detach, posing a choking hazard to young children.

    Product
    Three styles of Plush Grumpy Cat stuffed animal toys.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1189-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The sterile, single-use devices are distributed worldwide.

    Product
    G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1161-2014·2014-03-19

    Smith & Nephew RENASYS-G Gauze Dressing Kit Recall for Sealing Issues

    Smith & Nephew is recalling RENASYS-G Sterile Gauze Dressing Kits due to inadequate Soft Port sealing that may prevent fluid evacuation and fail to trigger alarms.

    Product
    Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are used for in-vitro diagnostic blood sampling.

    Product
    4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1199-2014·2014-03-19

    GE Healthcare Recalls Varicam and VG Hawkeye Imaging Devices

    GE Healthcare is recalling Varicam and VG Hawkeye nuclear medicine devices due to a potential safety issue where the detector may drift toward the patient.

    Product
    GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2014·2014-03-19

    GE Healthcare Recalls Elscint APEX Helix Gamma Cameras for Motion Risk

    GE Healthcare is recalling 3,062 Elscint APEX Helix gamma cameras due to a potential safety issue where the detector may drift toward the patient.

    Product
    Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scannin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2014·2014-03-19

    Horiba Medical Recalls ABX PENTRA ML Software Due to Data Transmission Bug

    Horiba Medical is recalling ABX PENTRA ML software because a bug may transmit incorrect results to Laboratory Information Systems.

    Product
    Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1163-2014·2014-03-19

    GE Healthcare Recalls Innova X-ray Systems for Unexpected Power Loss

    GE Healthcare is recalling Innova cardiovascular X-ray systems because they may unexpectedly stop delivering X-rays, causing a loss of real-time imaging.

    Product
    GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1646-2014·2014-03-19

    Meijer Pretzel Dinner Rolls Recalled for Unlabeled Milk Allergen

    Meijer Distribution is recalling Pretzel Dinner Rolls because milk is not listed as an allergen. People with milk allergies risk serious reactions.

    Product
    Markets of Meijer Pretzel Dinner Roll, 8 count, 14.0 oz ( 0.87 lb) UPC 0-4125099036-9 Ingredients: Enriched Flour ( Wheat Flour, Malted Barley Flour, niacin, iran, thiamine mononitrate....) water, sugar, canola oil, salt, why (milk) , yeast, wheat starch soy lecithin, wheat g
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1651-2014·2014-03-19

    Hudson Valley Homestead Bushwhacker's Savory Sauce Recalled for Undeclared Anchovies

    Charlemagne's Tree Farm recalled Hudson Valley Homestead Bushwhacker's Savory Sauce due to undeclared anchovies.

    Product
    HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Hot & Spicy, Net Wt. 14 oz., UPC 7 51122 00092 1, Hudson Valley Homstead 102 Sheldon Lane Craryville, New York 12521 (518) 851-7336, www.hudsonvalleyhomstead.com
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1652-2014·2014-03-19

    Mary Ann's Chocolates Recalled for Missing Allergen and Ingredient Labels

    Savory Foods, Inc. is recalling Mary Ann's Chocolates Signature Assortments because the ingredient panels failed to list peanuts, specific tree nuts, soy, and certain food dyes.

    Product
    MARY ANN'S Chocolates Signature Assortment,May Contain Sugar, Chocolate, Butter, Corn Syrup, Assorted Fruit and Nuts, Coconut, Vegetable Oil, Egg or Vegetable Albumen , Salt, Natural and Artificial Flavors and Certified Food Colors. Fruits Contain Sulfur Dioxide, Savory Foods
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1164-2014·2014-03-19

    Boston Scientific Recalls RunWay Guide Catheters Due to Sterility Concerns

    Boston Scientific is recalling seven RunWay Guide Catheters because their sterile pouches may not be completely sealed, potentially compromising sterility.

    Product
    Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1194-2014·2014-03-19

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Q-CPR Meter Display Error

    Philips is recalling HeartStart MRx Monitor/Defibrillators with the Q-CPR Meter option because the device may incorrectly display a 'Do Not Touch the Patient' icon during defibrillation mode.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the op
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1647-2014·2014-03-19

    Nicomex Camaron Entero Whole Shrimp Recalled for Undeclared Sulfites

    Nicomex Inc. is recalling Camaron Entero Whole Shrimp due to undeclared sulfites identified by NYSDAM Laboratory analysis.

    Product
    Nicomex Camaron Entero Whole Shrimp Net Wt 1 oz (28.35 grams). Productos Mexicanos Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 Tel. (973) 815-2062. UPC 8 84678 10173 9.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1667-2014·2014-03-19

    Pecan Shed Recalls Candied Pecans Due to Undeclared Soy Allergen

    Pecan Shed is recalling milk chocolate candied pecans because they contain undeclared soy. The product was sold in retail stores and online to customers in several states.

    Product
    Candied pecans: milk chocolate
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1644-2014·2014-03-19

    StoneWall Kitchen Cupcake Mix Recalled for Missing Milk Allergen Labeling

    Raymond-Hadley Corp. is recalling StoneWall Kitchen Chocolate Coconut Cupcake Mix because the packaging fails to list milk as an allergen, despite containing sodium caseinate.

    Product
    STONEWALL KITCHEN brand Chocolate Coconut Cupcake Mix, Net Wt. 22.5 oz. (637.9 g), UPC 7 11381 31535 4 -- DISTRIBUTED BY STONEWALL KITCHEN, STONEWALL LANE, YORK, ME 03909
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1650-2014·2014-03-19

    Hudson Valley Homestead Bushwhacker's Savory Sauce Recalled for Undeclared Anchovies

    Hudson Valley Homestead is recalling Bushwhacker's Savory Sauce due to undeclared anchovies, a potential allergen hazard.

    Product
    HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Mild, Net Wt. 14 oz., UPC: 7 51122 00091 0, Hudson Valley Homstead 102 Sheldon Lane Craryville, New York 12521 (518) 851-7336, www.hudsonvalleyhomstead.com
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1151-2014·2014-03-19

    Megadyne Recalls Suction Coagulators Due to Self-Activation Risk

    Megadyne Medical Products is voluntarily recalling specific lots of Hand Control 12FR Suction Coagulators because they may self-activate when connected to a generator.

    Product
    Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1174-2014·2014-03-19

    Synthes Small Notch Titanium Reconstructive Plate Recalled for Contraindicated Spine Use

    Synthes, Inc. is recalling Small Notch Titanium Reconstructive Plate sets distributed for spine applications where they are contraindicated.

    Product
    Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1649-2014·2014-03-19

    Morrison's Brown Gravy Mix Recalled for Undeclared Soy Allergen

    C. H. Guenther & Sons, Inc. is recalling Morrison's Brown Gravy Mix mislabeled as pancake mix due to undeclared soy.

    Product
    MORRISON'S BROWN GRAVY MIX, NET WT 13 OZ (369 g) mislabeled as MORRISON'S PANCAKE MIX, NET WT 5 LB (2.27 kg)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1187-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The devices are sterile, single-use, and used for drawing arterial blood.

    Product
    4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood v
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1168-2014·2014-03-19

    Biomet 3i Recalls Tapered Navigator Surgical Kits Due to Sterility Failure

    Biomet 3i is recalling 170 Tapered Navigator Certain Surgical Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1165-2014·2014-03-19

    Maquet Plegiox Cardioplegia Heat Exchanger Recalled for Temperature Discrepancy

    Maquet is recalling 1,424 Plegiox Cardioplegia Heat Exchangers because they may fail to reach the desired cardioplegia temperature when used with a heater/cooler unit.

    Product
    MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1162-2014·2014-03-19

    Smith & Nephew RENASYS-AB Abdominal Dressing Kit Recall for Sealing Defects

    Smith & Nephew is recalling RENASYS-AB Abdominal Dressing Kits because inadequate sealing may prevent fluid evacuation and fail to trigger pump alarms.

    Product
    Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1158-2014·2014-03-19

    Smith & Nephew RENASYS-F Foam Dressing Kit Recall for Sealing Issues

    Smith & Nephew is recalling RENASYS-F Foam Dressing Kits with Soft Port due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.

    Product
    Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 181 dental torque driver kits because they failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2014·2014-03-19

    GE Healthcare Recalls Infinia Nuclear Medicine Systems for Detector Motion Risk

    GE Healthcare is recalling Infinia and Infinia Hawkeye Nuclear Medicine Systems due to a potential safety issue where the detector may drift toward the patient.

    Product
    GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 541 Contra-Angle Torque Driver Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1185-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The p
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1170-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 250 Contra-Angle Torque Driver Kits because the included surgical trays failed to meet required Sterility Assurance Levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1668-2014·2014-03-19

    Pecan Shed Recalls Candied Pecans Due to Undeclared Soy Allergen

    Pecan Shed is recalling Candied Pecans: Dark Chocolate because the product contains undeclared soy. The recall affects customers in nine states and Washington DC.

    Product
    Candied pecans: dark chocolate
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1669-2014·2014-03-19

    Pecan Shed Recalls Candied Pecans Due to Undeclared Soy Allergen

    Pecan Shed is recalling Candied Pecans: creamy white because they contain undeclared soy. The product was sold in-store and online to customers in several states.

    Product
    Candied pecans: creamy white
    Category
    Food
    Distribution
    10 states

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