The Recall Desk

Archive

April 2014 recalls

645 recalls were announced in April 2014.

What the numbers show

Critical
60
Severe
147
High
256
Moderate
162
Low
20

Of the 645 recalls this month scored against our rubric, 9% are Critical, 23% are Severe.

401–500 of 645

  • ModerateFDA (Devices)·Z-1349-2014·2014-04-16

    LumiQuick Strep A Test Card Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling Strep A Test Cards because they were shipped to US locations without required FDA clearance.

    Product
    Strep A Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1359-2014·2014-04-16

    LumiQuick Dengue Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling all lots of its Dengue NS1 Ag/IgG/M Ab Duo Test Cards because they were shipped to US locations without the required FDA clearance.

    Product
    Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1366-2014·2014-04-16

    LumiQuick Recalls Tramadol Strips Shipped Without FDA Clearance

    LumiQuick Diagnostics Inc. is recalling all lots of Tramadol Strips (Catalog 74003) because they were shipped to US locations without approved FDA applications or clearance.

    Product
    Tramadol Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1334-2014·2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.

    Product
    5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1337-2014·2014-04-16

    LumiQuick Syphilis Test Strips Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling all lots of Syphilis Test Strips (Serum) because they were shipped to locations without approved FDA clearance.

    Product
    Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1375-2014·2014-04-16

    LumiQuick Cocaine Test Card Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling Cocaine Test Cards because they were shipped to US locations without required FDA clearance.

    Product
    Cocaine Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1413-2014·2014-04-16

    LumiQuick Myoglobin Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling Myoglobin Test Cards (Serum) because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1367-2014·2014-04-16

    LumiQuick Drugs of Abuse Panel Test Device Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling its Drugs of Abuse Panel Test Device because it was shipped to locations without required FDA approvals.

    Product
    Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1370-2014·2014-04-16

    LumiQuick Barbiturate Strip Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Barbiturate Strips shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Barbiturate Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-1755-2014·2014-04-16

    Smiley National Recalls Kratom Supplements Due to Unapproved Ingredients

    Smiley National is voluntarily recalling specific Kratom herbal dietary supplements because they contain unapproved dietary ingredients.

    Product
    Enhanced Bali Leaf Powder, Max Kratom, Capsule, UPC Code 5410600332, 20 count pack, 5 servings per pack, Herbal Dietary Supplement.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1343-2014·2014-04-16

    LumiQuick Salmonella typhi Antigen Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling Salmonella typhi Antigen Test Cards because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1368-2014·2014-04-16

    LumiQuick Amphetamine Strip Recalled for Unapproved US Distribution

    LumiQuick Diagnostics is recalling Amphetamine Strips shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Amphetamine Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1358-2014·2014-04-16

    LumiQuick Dengue NS1 Antigen Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling all lots of the Dengue NS1 Antigen Test Card because the products were shipped to US locations without approved regulatory clearance.

    Product
    Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1357-2014·2014-04-16

    LumiQuick Malaria Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics Inc. is recalling Malaria pf/pan Antigen Test Cards because they were shipped to locations without approved FDA applications or clearance.

    Product
    Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1350-2014·2014-04-16

    LumiQuick Malaria Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling Malaria pf Antigen Test Cards because they were shipped to locations without approved FDA applications or clearance.

    Product
    Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-1757-2014·2014-04-16

    Smiley National Recalls Kratom Supplements Due to Unapproved Ingredients

    Smiley National is voluntarily recalling specific Kratom herbal dietary supplements because they contain unapproved dietary ingredients.

    Product
    All Natural, XL Kratom, Herbal Dietary Supplement, capsule, UPC code 5410600307, 4 capsules per package.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1758-2014·2014-04-16

    Smiley National Recalls Kratom Products Due to Unapproved Ingredients

    Smiley National is voluntarily recalling four kratom products because they contain unapproved dietary ingredients.

    Product
    Natural Bali Kratom 40, capsule, UPC code 5410600335, 20 capsules per bottle.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1354-2014·2014-04-16

    LumiQuick Salmonella Typhi Test Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling Salmonella typhi IgG/IgM Duo Tests because they were shipped to US locations without required FDA clearance.

    Product
    Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1387-2014·2014-04-16

    LumiQuick Morphine Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Morphine Test Cards because they were shipped to locations without required FDA approvals.

    Product
    Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1391-2014·2014-04-16

    LumiQuick THC Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics Inc. is recalling THC Test Cards shipped to US locations without approved FDA applications.

    Product
    THC Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1360-2014·2014-04-16

    LumiQuick Fecal Occult Blood Test Cards Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling Fecal Occult Blood Test Cards because they were shipped to locations without approved FDA applications or clearances.

    Product
    Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1399-2014·2014-04-16

    LumiQuick Propoxyphene Test Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling Propoxyphene Test Strips because they were shipped to US locations without approved applications for PMA, IDE, or 510(k) clearance.

    Product
    Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1386-2014·2014-04-16

    LumiQuick Morphine Strips Recalled for Unapproved US Distribution

    LumiQuick Diagnostics is recalling Morphine Strips (2000) because they were shipped to US locations without required FDA clearance.

    Product
    Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1392-2014·2014-04-16

    LumiQuick Ketamine Strip Recalled for Unapproved US Distribution

    LumiQuick Diagnostics is recalling all lots of its Ketamine Strip because the products were shipped to US locations without required FDA clearance.

    Product
    Ketamine Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1342-2014·2014-04-16

    LumiQuick H. Pylori Antibody Test Card Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics Inc. is recalling H. Pylori Antibody Test Cards because they were shipped to locations without required FDA regulatory clearances.

    Product
    H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1380-2014·2014-04-16

    LumiQuick Methadone Test Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Methadone Test Strips because they were shipped to US locations without approved applications for PMA, IDE, or 510(k) clearance.

    Product
    Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1381-2014·2014-04-16

    LumiQuick Methadone Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling Methadone Test Cards because they were shipped to locations without approved FDA applications or clearance.

    Product
    Methadone Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1346-2014·2014-04-16

    LumiQuick Adeno/Rota Combo Test Card Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics Inc. is recalling Adeno/Rota Combo Test Cards because they were shipped to US locations without required FDA regulatory approvals.

    Product
    Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1351-2014·2014-04-16

    LumiQuick Malaria pf Antigen Test Card Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics is recalling Malaria pf Antigen Test Cards because they were shipped to US locations without required FDA regulatory clearance.

    Product
    Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1348-2014·2014-04-16

    LumiQuick H. Pylori Test Cards Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics is recalling H. Pylori Ab Test Cards because they were shipped to locations without approved FDA applications.

    Product
    H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1340-2014·2014-04-16

    LumiQuick Dengue IgG/IgM Tests Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling all lots of its Dengue IgG/IgM tests because they were shipped to US locations without required FDA clearance.

    Product
    Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1384-2014·2014-04-16

    LumiQuick Morphine Strip Recalled for Unapproved Distribution in US

    LumiQuick Diagnostics is recalling Morphine Strip (300) products distributed in California, Florida, New Jersey, Texas, and New York because they were shipped to locations without approved applications for PMA, IDE, or 510(k) clearance.

    Product
    Morphine Strip (300); LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1404-2014·2014-04-16

    LumiQuick Fentanyl Test Card Recalled for Unauthorized Distribution

    LumiQuick Diagnostics Inc. is recalling Fentanyl Test Cards because they were shipped to US locations without approved FDA applications.

    Product
    Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1441-2014·2014-04-16

    Remington Medical Recalls FAS-LOC Extension Cables Due to Labeling Error

    Remington Medical is recalling FAS-LOC 6 Foot Disposable Extension Cables because the instruction manual incorrectly displays the polarity for the black connector.

    Product
    FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1393-2014·2014-04-16

    LumiQuick Ketamine Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling all lots of the Ketamine Test Card because they were shipped to US locations without required FDA clearance.

    Product
    Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1362-2014·2014-04-16

    LumiQuick PSA Test Card Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics Inc. is recalling PSA Test Cards (Whole Blood) because they were shipped to US locations without approved FDA applications or clearance.

    Product
    PSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1415-2014·2014-04-16

    LumiQuick CK-MB Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling CK-MB Test Cards shipped to US locations without required FDA clearance.

    Product
    CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1409-2014·2014-04-16

    LumiQuick Troponin I Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to locations without required FDA clearance.

    Product
    Troponin I test Card (serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Drugs)·D-1227-2014·2014-04-16

    Novartis Recalls Ritalin Tablets Due to Incorrect Medication Guide Labeling

    Novartis is recalling Ritalin tablets because the attached Medication Guide contained information for the sustained-release version. The recall is limited to a specific lot distributed nationwide and in Puerto Rico.

    Product
    RITALIN — RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1228-2014·2014-04-16

    Novartis Recalls Ritalin Tablets Due to Incorrect Medication Guide Labeling

    Novartis is recalling 10,781 bottles of Ritalin 20 mg tablets because the attached Medication Guide contained information for Ritalin SR instead of Ritalin Tablets.

    Product
    RITALIN — RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1226-2014·2014-04-16

    Hospira Recalls Demerol Ampoules Due to Missing Container Labels

    Hospira Inc. is recalling 237,850 ampoules of Demerol (meperidine HCL) because the immediate container labels are missing. The recall is nationwide.

    Product
    Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V182000·2014-04-15

    Volkswagen Recalls 2014 Models for Transmission Fluid Leak Fire Risk

    Volkswagen is recalling 2014 Jetta, Beetle, and Passat vehicles because leaking transmission fluid could contact hot surfaces and cause a fire.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT, JETTA, BEETLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E017000·2014-04-15

    Carrier Trailer Refrigeration Units Recalled for Wiring Fire Risk

    Carrier is recalling specific trailer refrigeration units and part kits because a bolt may abrade wiring, increasing the risk of a fire.

    Product
    ELECTRICAL SYSTEM:WIRING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·015-2014-EXP·2014-04-14

    Nutriom LLC Recalls Dried Egg Products Due to Possible Salmonella Contamination

    Nutriom LLC is recalling dried egg products due to possible Salmonella contamination. The recall includes an additional 82,884 pounds of product.

    Product
    Washington Firm Recalls Dried Egg Products Due To Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V195000·2014-04-11

    Open Range LF319 Trailer Recall for Short Kitchen Gas Line

    Open Range is recalling 2014 LF319 fifth wheel trailers because a short gas line in the kitchen slideout may leak when expanded, increasing fire risk.

    Product
    OPEN RANGE — OPEN RANGE LF319
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V177000·2014-04-11

    Mercedes-Benz Recalls C-Class Vehicles for Tail Light Electrical Defect

    Mercedes-Benz is recalling 2008-2011 C300, C350, and C63 AMG vehicles because a poor electrical ground may cause tail lights to dim or fail, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ C350, C300, C63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V171000·2014-04-10

    GM Recalls Vehicles for Ignition Key Removal Defect

    General Motors is recalling specific Saturn, Chevrolet, and Pontiac vehicles because the ignition key can be removed while the engine is running, creating a rollaway risk.

    Product
    SATURN — SATURN, CHEVROLET, PONTIAC ION, COBALT, SOLSTICE, HHR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V176000·2014-04-10

    BMW Recalls 2010-2012 Models for Engine Bolt Failure Risk

    BMW is recalling approximately 156,137 vehicles because VANOS housing bolts may loosen or break, potentially causing the engine to stall and increasing crash risk.

    Product
    BMW — BMW 128I, 135I, 328I, 535I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V189000·2014-04-10

    MV Agusta Recalls 2014 Motorcycles Due to Swingarm Bolt Failure Risk

    MV Agusta is recalling 223 model year 2014 motorcycles because a swingarm bolt may fail, increasing the risk of a crash.

    Product
    MV AGUSTA — MV AGUSTA BRUTALE RR, F3 675, RIVALE 800, F3 800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V190000·2014-04-10

    Forest River Recalls 2014 Vibe Travel Trailers for Incorrect Certification Labels

    Forest River is recalling 164 model year 2014 Vibe travel trailers because the Federal Certification Label lists incorrect tire and weight information, which could lead to overloading and tire failure.

    Product
    VIBE — VIBE VCT6504, VCT6501, VCT6502, VCT6503
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E015000·2014-04-10

    Villa Recalls Defective Seat Belts in Jayco, Tiffin, and American Coach RVs

    Villa International is recalling specific driver and passenger seats used in 2014-2015 Jayco, Tiffin, and American Coach recreational vehicles because the seat belt attachment may be incorrect and the belt may fray, reducing its strength.

    Product
    JAYCO — JAYCO, TIFFIN, AMERICAN COACH ENTEGRA CORNERSTONE, ZEPHYR, ALLEGRO, AMERICAN TRADITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14729·2014-04-10

    Whalen Recalls Stainless Steel Tool Chests Due to Laceration Hazard

    Whalen is recalling approximately 20,000 stainless steel tool chests sold at Costco due to a sharp metal edge on the right door that poses a laceration hazard.

    Product
    Stainless steel tool chests
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14146·2014-04-10

    BedHead Recalls Children's Pajamas for Flammability Standard Violations

    BedHead Pajamas Inc. is recalling about 800 children's two-piece pajama sets because they fail to meet federal flammability standards, posing a risk of burn injuries.

    Product
    Children's Two-Piece Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1711-2014·2014-04-09

    Roos Foods Recalls Queso Fresco Anita Due to Listeria Risk

    Roos Foods Inc is recalling Queso Fresco Anita and other cheese products because samples of a related product tested positive for Listeria monocytogenes.

    Product
    Queso Fresco Anita, 16 oz., packaged in a rigid plastic container (Clamshell), Kenton, DE 19955 Plant No. 10-5436.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1710-2014·2014-04-09

    Roos Foods Recalls Fresh Cheese Products Due to Listeria Monocytogenes Findings

    Roos Foods, Inc. is recalling Santa Rosa de Lima fresh cheese products after samples tested positive for Listeria monocytogenes. The recall covers all brands, lots, and sizes from the facility.

    Product
    Santa Rosa de Lima Queso de Huerta (Fresh Cheese), 12 oz. packaged in a rigid plastic container (Clamshell), Manufacturado y Distribuido por (manufactured and distributed for) Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003859. (Ingredients: Pasteurized
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1706-2014·2014-04-09

    Roos Foods Recalls Requeson Mexicana Ricotta Due to Listeria Risk

    Roos Foods Inc. is recalling Requeson Mexicana Part-Skim Ricotta because samples of a related cheese product tested positive for Listeria monocytogenes.

    Product
    Requeson Mexicana Part-Skim Ricotta, 15 oz., packaged in a plastic cup, Distributed by Roos Foods Inc., Kenton, DE 19955, UPC code 095548003415, (Ingredients: Pasteurized milk, whey, skim milk, cultured milk, solids, carrageenan, salt, potassium sorbate, (preservative)) . Re
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1712-2014·2014-04-09

    Roos Foods Recalls Queso Fresco and Other Cheeses for Listeria Risk

    Roos Foods is recalling Mexicana Brand Queso Fresco and other cheeses due to Listeria monocytogenes found in samples. The recall covers all brands, lots, and sizes from the facility.

    Product
    Mexicana Brand Queso Fresco Fresh Cheese, 16 oz. Wrapped in cellophane, ) Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003330 (Ingredients: Cultured and pasteurized milk, salt).
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1709-2014·2014-04-09

    Roos Foods Recalls Santa Rosa de Lima Grated Cheese for Listeria

    Roos Foods is recalling Santa Rosa de Lima grated cheese after samples of a related product tested positive for Listeria monocytogenes.

    Product
    Santa Rosa de Lima Queso Rallado Aserrin (Grated Cheese) Queso Duro Viejo packaged in a 16 oz Plastic Pouch, Manufactured by Roos Foods, Inc. Kenton, DE 19955, Plant No. 10-5436, Distributed by: Roos Foods Distributors, 645 Lofstrand Lane, Rockville, MD 20850, UPC code 0955480034
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1740-2014·2014-04-09

    Sweet Street Desserts Macaroni and Cheese Recalled for Listeria

    Perfect Pasta is recalling Sweet Street Desserts brand macaroni and cheese due to the presence of Listeria monocytogenes.

    Product
    Macaroni and cheese packaged in plastic bags, 12 oz. to a bag, and sold under the Sweet Street Desserts brand. Cases of product contain 36 bags for a total case weight of 27 lbs.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1717-2014·2014-04-09

    Roos Foods Recalls Santa Rosa de Lima Fresh Cheese for Listeria

    Roos Foods Inc. is recalling Santa Rosa de Lima Cuajada Fresca fresh cheese after samples tested positive for Listeria monocytogenes.

    Product
    Santa Rosa de Lima Cuajada Fresca (Fresh Cheese) , 16 oz packed in a rigid plastic container (Clamshell), Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003538. (Ingredients: Pasteurized whole milk, enzymes, rennet & salt).
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1716-2014·2014-04-09

    Roos Foods Recalls Fresh Cheese Products Due to Listeria Contamination

    Roos Foods Inc. is recalling all brands and lots of fresh cheese products manufactured or repackaged at its Kenton, Delaware facility after samples tested positive for Listeria monocytogenes.

    Product
    Mexicana Brand Cuajada Fresca (Fresh Cheese) 16 oz., packaged in a rigid plastic container (Clamshell), Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003606. (Ingredients: Cultures, pasteurized milk, salt). Amigo Brand Cuajada Fresca (Fresh Cheese), 16 oz.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1726-2014·2014-04-09

    Belmont Premium Ice Cream Recalled for Undeclared Nut Allergen

    House Of Flavors, Inc. is recalling Belmont Premium Ice Cream, Chocolate Chip Cookie Dough, because it may contain undeclared nut allergen.

    Product
    Belmont Premium Ice Cream, Chocolate Chip Cookie Dough, All Natural, 1.5 Quarts (1.42 L), Nutrition Facts....., Ingredients: Skim milk, Cream, Sugar, Cookie dough pieces (unenriched wheat flour, sugar, butter (cream, salt), brown sugar, water, corn oil, fructose, corn syrup sol
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1714-2014·2014-04-09

    Roos Foods Recalls Santa Rosa De Lima Queso Fresco for Listeria

    Roos Foods Inc. is recalling Santa Rosa De Lima Queso Fresco because samples tested positive for Listeria monocytogenes. The recall covers all brands, lots, and sizes from the facility.

    Product
    Santa Rosa De Lima Queso Fresco Round Fresh Cheese, packaged in 80 oz (5 lbs) cellophane wrapping, Manufacturado por (manufactured for) Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436,UPC code 095548003569. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, culture
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1707-2014·2014-04-09

    Roos Foods Recalls Santa Rosa de Lima Hard Cheese for Listeria

    Roos Foods Inc. is recalling Santa Rosa de Lima hard cheese after samples of a related product tested positive for Listeria monocytogenes.

    Product
    Santa Rosa de Lima Queso Duro Blando (Hard Cheese), packaged in 14 oz and 8 oz clear, rigid plastic containers (Clamshell), Manufacturado por (manufactured for) Roos Foods Inc., Kenton, DE 19955, Plant No. 10-5436, UPC codes 095548003194 and 095548003118. (Ingredients: Pasteuri
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1715-2014·2014-04-09

    Roos Foods Recalls Fresh Cheese Products Due to Listeria Monocytogenes

    Roos Foods Inc. is recalling fresh cheese products after samples tested positive for Listeria monocytogenes. The recall covers multiple brands and all lots distributed in the Mid-Atlantic region.

    Product
    Mexicana Cuajadita Casera (Fresh Cheese), 16 oz. wrapped in cellophane on a styrofoam tray, Roos Foods Inc., Kenton, DE 19955 Plant No. 10-5436, UPC code 095548003651. (Ingredients: Cultures, pasteurized milk, salt, natamycin (mold inhibitor)). Santa Rosa de Lima Cuajadita Cas
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1708-2014·2014-04-09

    Roos Foods Recalls Queso Cotija Due to Listeria Contamination

    Roos Foods Inc. is recalling Mexicana Brand Queso Cotija Molido because samples of a related cheese product tested positive for Listeria monocytogenes.

    Product
    Mexicana Brand Queso Cotija Molido packaged in 1, 6 oz rigid plastic containers (Clamshell), Distributed/Distribuido por: Roos Foods Inc., DE 19955, UPC code 095548001435. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, lactic acid).
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1739-2014·2014-04-09

    Kirkland Signature Real Sliced Fruit Recalled for Salmonella Contamination

    Oregon Freeze Dry Inc. is recalling Kirkland Signature Real Sliced Fruit due to Salmonella contamination. The product was distributed to 37 states and Puerto Rico.

    Product
    Kirkland Signature brand Real Sliced Fruit, Item # 527069. The UPC on the master cardboard case is 0 96619 52706 9. Each cardboard case consists of 20 plastic pouches (7.41 oz): 10 pouches of Fuji Apple Slices, 5 pouches of Strawberry Banana Slices, and 5 pouches of Fuji Appl
    Category
    Food
    Distribution
    37 states
  • CriticalFDA (Food)·F-1718-2014·2014-04-09

    Roos Foods Recalls Santa Rosa de Lima Fresh Cheese Curd for Listeria

    Roos Foods Inc. is recalling Santa Rosa de Lima Cuajada en Terron fresh cheese curd because samples tested positive for Listeria monocytogenes.

    Product
    Santa Rosa de Lima Cuajada en Terron (Fresh Cheese Curd), 16 oz packaged in a plastic bag, Roos Foods Inc., Kenton, DE, 19955, Plant No. 10-5436, UPC code 095548003033. (Ingredients: Pasteurized whole milk, enzymes, rennet & salt). Santa Rosa de Lima Cuajada en Terron, packa
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1724-2014·2014-04-09

    Fresh To Go Tuscan Style Sandwiches Recalled for Undeclared Pine Nuts

    H.C. Schau & Son is recalling Fresh To Go Tuscan Style Combo sandwiches because they contain undeclared pine nuts, a tree nut allergen.

    Product
    8 oz. Tuscan Style Combo on Tomato Basil Spread sandwiches individually wrapped in clear plastic wrap sold under the Fresh To Go brand.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·14V169000·2014-04-09

    Toyota Recalls Yaris and Scion xD for Seat Rail Spring Defect

    Toyota is recalling 2006-2010 Yaris and 2008-2010 Scion xD vehicles because seat rail springs may break, potentially allowing the seat to move during a crash.

    Product
    TOYOTA — TOYOTA, SCION YARIS, XD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V168000·2014-04-09

    Toyota and Pontiac Vehicles Recalled for Driver Airbag Cable Defect

    Toyota and General Motors are recalling specific 2006-2010 vehicles because a steering cable defect may prevent the driver's airbag from deploying in a crash.

    Product
    TOYOTA — TOYOTA, PONTIAC TACOMA, YARIS, VIBE, COROLLA MATRIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1744-2014·2014-04-09

    Net Food Turkey Dried Apricots Recalled for Undeclared Sulfites

    Net Food Import and Export LLC is recalling Turkey Dried Apricots because NYSDAM analysis found undeclared sulfites. The product was distributed in New Jersey.

    Product
    Net Food Turkey Dried Apricots Net Weight 16.1 oz (454 g) Thunderbolt Export & Imports 743 Fairview Avenue. Suit :2 Arcadia, CA 91007 USA UPC 8697445250019
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V179000·2014-04-09

    Winnebago Recalls 2014-2015 Motorhomes for Brake Hose Defect

    Winnebago is recalling specific 2014-2015 motorhomes because a manufacturing defect may have damaged brake hoses, potentially causing fluid leakage and reduced braking performance.

    Product
    WINNEBAGO — WINNEBAGO TRAVATO, ITASCA VIVA, TREND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1723-2014·2014-04-09

    Roos Foods Recalls La Chapina Cream Due to Listeria Contamination

    Roos Foods Inc is recalling La Chapina Crema Guatemalteca because samples of a related cheese product tested positive for Listeria monocytogenes.

    Product
    La Chapina Crema Guatemalteca Guatemalan Style Cream, 16 oz. packaged in a plastic bag, Distribuido por: Roos Foods Distributors, 645 Lofstrand Lane, Rockville, MD 20850, UPC code 095548000414. (Ingredients: Cream, milk, water, salt, nonfat dry milk, cultured skim milk powder,
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1721-2014·2014-04-09

    Roos Foods Recalls Amigo Brand Sour Cream Due to Listeria Contamination

    Roos Foods is recalling Amigo Brand Crema Centroamericana Cultured Sour Cream because Listeria monocytogenes was found in samples of cheese from the same facility.

    Product
    Amigo Brand Crema Centroamericana Cultured Sour Cream, Grade A, 16 oz., packed in a plastic jar, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 09554800079. (Ingredients: Cream, milk, salt, nonfat dry milk, skim milk powder, gelatin, stabilizers (carrageean gum
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1719-2014·2014-04-09

    Roos Foods Recalls Santa Rosa de Lima Sour Cream Due to Listeria

    Roos Foods is recalling Santa Rosa de Lima sour cream products because Listeria monocytogenes was found in samples of fresh curd cheese from the same facility.

    Product
    Santa Rosa de Lima Crema Salvadorena Cultured Sour Cream, 80 oz. (5lbs), packaged in a Plastic Tub, Roos Foods, Inc., Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003934. Santa Rosa de Lima Crema Salvadorena Culture Sour Cream, Grade A, 16 oz., packed in a plastic jar, Ro
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1704-2014·2014-04-09

    Mrs. Griffin's Barbecue Sauce Recalled for Undeclared Milk Allergen

    Bar-Jim Inc. is recalling Mrs. Griffin's Original Barbecue Sauce because it contains undeclared milk, a major food allergen.

    Product
    Mrs. Griffin's Original Barbecue Sauce, Net 32 Fl.oz. (946 mL), Made by Griffin Barbecue Sauce, Inc., Macon GA 31206
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1722-2014·2014-04-09

    Roos Foods Recalls Santa Rosa de Lima Cheese Due to Listeria

    Roos Foods is recalling Santa Rosa de Lima cheese products after samples tested positive for Listeria monocytogenes. The recall includes all brands, lots, and sizes from the facility.

    Product
    Santa Rosa de Lima Mantequilla de Bolsa Tradicion Centroamericana, 15 oz., packaged in a plastic bag, Manufactured by Roos Foods, Inc., UPC code 095548002159. (Ingredients: Cream, milk, water, salt, nonfat dry milk, cultured skim powder, gelatin, stabilizers (carrageean gum, dis
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1189-2014·2014-04-09

    FDA Recalls HydrOXYzine HCl Tablets Due to Unapproved Ingredient Source

    American Health Packaging is recalling HydrOXYzine HCl 50 mg tablets because the active ingredient came from an unapproved source.

    Product
    HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1308-2014·2014-04-09

    RaySearch Ray Station 4.0 software recalled for dose calculation errors

    RaySearch Laboratories is recalling Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.

    Product
    RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1311-2014·2014-04-09

    Zoll Medical Defibrillators Recalled for Continuous Device Reset Loop

    Zoll Medical is recalling 3,169 defibrillator/pacemaker/monitor units because they may latch in a continuous reset loop, rendering them unusable.

    Product
    Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1713-2014·2014-04-09

    Roos Foods Recalls Queso Fresco Due to Listeria Monocytogenes Contamination

    Roos Foods Inc. is recalling Amigo Brand Queso Fresco because samples of related cheese products tested positive for Listeria Monocytogenes.

    Product
    Queso Fresco Amigo Brand Round Fresh Cheese, 16 oz. wrapped in cellophane, Manufactured by: Roos Foods, Inc. Kenton, DE 19955, Plant No. 10-5436, UPC code 095548003316. (Ingredients: Pasteurized whole milk, salt, rennet, calcium, lactic acid).
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1320-2014·2014-04-09

    Merit Medical Systems Recalls Non-Sterile Custom Syringe Kits

    Merit Medical Systems is recalling 15 syringe kits labeled as sterile but not sterilized. The products were distributed in the US, Thailand, and Hong Kong.

    Product
    Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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