The Recall Desk

Archive

January 2019 recalls

247 recalls were announced in January 2019.

What the numbers show

Critical
18
Severe
91
High
87
Moderate
42
Low
9

Of the 247 recalls this month scored against our rubric, 7% are Critical, 37% are Severe.

201–247 of 247

  • CriticalFDA (Food)·F-0820-2019·2019-01-02

    Apio Recalls Eat Smart Salad Shake Ups Due to Listeria

    Apio, Inc. is recalling specific varieties of Eat Smart Salad Shake Ups after the Canadian Food Inspection Agency detected Listeria monocytogenes.

    Product
    Eat Smart Salad Shake Ups - Raspberry Acai/Framboises ET: 5.5 oz. (156 g); US UPC 7 09351-30178 0; Canadian UPC: 7 09351 30196 4. Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-0818-2019·2019-01-02

    Apio Recalls Eat Smart Salad Shake Ups Due to Listeria

    Apio, Inc. is recalling specific varieties of Eat Smart Salad Shake Ups after the Canadian Food Inspection Agency detected Listeria monocytogenes.

    Product
    Eat Smart Salad Shake Ups - Asian Sesame/Sesame Asiatique; 5.5 oz. (156 g); UPC 7 09351-30241 1, 7 09351 30244 2 Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Drugs)·D-0347-2019·2019-01-02

    Phenylephrine HCl Injectable Solution Recalled for Incorrect Concentration Labeling

    Advanced Pharma Inc. is recalling 225 syringes of Phenylephrine HCl injectable solution because the label incorrectly states the concentration as 10 mcg per mL instead of 100 mcg per mL.

    Product
    Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
    Category
    Drug
    Distribution
    3 states
  • CriticalNHTSA·19E003000·2019-01-02

    Takata Frontal Passenger Air Bag Inflator Recall for 2010+ Vehicles

    Takata is recalling specific frontal passenger air bag inflators in 2010 or newer vehicles registered in 22 states due to a risk of explosion.

    Product
    AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0821-2019·2019-01-02

    Apio Recalls Eat Smart Salad Shake Ups Due to Listeria

    Apio, Inc. is recalling Eat Smart Salad Shake Ups after the Canadian Food Inspection Agency detected Listeria monocytogenes in the product.

    Product
    Eat Smart Salad Shake Ups - Sweet Kale/Chou Frise Doux: 5.5 oz. (156 g); US UPC 7 09351-30240 4; Canadian UPC: 7 09351 30243 5. Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-0663-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0672-2019·2019-01-02

    Tosoh Bioscience Recalls AIA-PACK Folate In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling AIA-PACK Folate reagents used for in vitro diagnostic testing due to a Class II safety concern.

    Product
    AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0822-2019·2019-01-02

    Apio Recalls Eat Smart Salad Shake Ups Due to Listeria Risk

    Apio, Inc. is recalling Eat Smart Salad Shake Ups after the Canadian Food Inspection Agency detected Listeria monocytogenes in the product.

    Product
    Eat Smart Salad Shake Ups - Tropical Lime/Lime Tropicale 5.5 oz. (156 g); US UPC 7 09351-30179 7; 7 09351 30197 1 Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-0758-2019·2019-01-02

    PICA-BOLA candy recalled for undeclared soy allergen

    Procesadora de Dulces Tipicos is recalling PICA-BOLA candy in the United States due to undeclared soy.

    Product
    1) PICA-BOLA 50 pieces Cont. Net 1 kg Net Wet. 2 lb 3.2 oz., packaged in a clear plastic ja, 6 jars per case and 2) PICA-BOLA 40 pieces Net Wet. 1 lb. 12.2 oz. packaged in a plastic bag, 11 bags per case and 3) PICA-BOLA 100 pieces Net Wt. 100-0.70 oz (4 lb 6.5 oz.) packaged in
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0759-2019·2019-01-02

    Flechazo Candy Recalled for Undeclared Soy Allergen

    Procesadora de Dulces Tipicos is recalling Flechazo candy due to undeclared soy, a major food allergen.

    Product
    FLECHAZO 36 pieces Net Wt. 1 lb. 12.5 oz. packaged in a clear plastic jar, 6 jars per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0760-2019·2019-01-02

    Tamy Pop Candy Recalled for Undeclared Soy Allergen

    Procesadora de Dulces Tipicos, S.A. de C.V. is recalling Tamy Pop candy due to undeclared soy. The recall covers 417 cases distributed in the United States.

    Product
    Tamy Pop 18 pieces Net Wt. 1 lb. 15.7 oz. packaged in a clear plastic jar, 6 jars per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0757-2019·2019-01-02

    El Super Leon Jabalina Xtreme candy recalled for undeclared soy

    Procesadora de Dulces Tipicos is recalling El Super Leon Jabalina Xtreme candy because it contains undeclared soy, a major food allergen.

    Product
    El Super Leon Jabalina Xtreme 50 pieces Net Wt. 2 lb. (3.2 oz.) Cont. Net. 1 kg packaged in a clear plastic jar, 6 jars per case
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·19V022000·2019-01-02

    Pierce Aerial Vehicles Recalled for Unexpected Ladder Rotation Defect

    Pierce Manufacturing is recalling 2004-2018 aerial vehicles because the aerial device may unexpectedly rotate right during extension, increasing injury risk.

    Product
    PIERCE — PIERCE VELOCITY, QUANTUM, IMPEL, ENFORCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling 1,760 units of Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0681-2019·2019-01-02

    Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Compromise

    Medical Action Industries is recalling 2,600 laparotomy sponges because a breach of the sterile barrier may have compromised product sterility.

    Product
    Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0686-2019·2019-01-02

    Elekta Recalls MOSAIQ Oncology Software Due to Isocenter Copying Error

    Elekta is recalling MOSAIQ Oncology Information System Version 2.64 because copied treatment fields may retain incorrect isocenter settings for imaging.

    Product
    MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0673-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK FT3 In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling ST AIA-PACK FT3 reagents used for in vitro diagnostic testing of Free Triiodothyronine. The recall covers 24,083 units distributed nationwide.

    Product
    ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0754-2019·2019-01-02

    Sargento Recalls Frozen Unbreaded Egg and Cheese Products for Listeria Risk

    Sargento Foods is recalling specific frozen unbreaded egg and cheese products due to potential Listeria monocytogenes or Salmonella contamination.

    Product
    Frozen Unbreaded Egg, Gouda, caramelized onion. Sample Number 18-0116.01. Keep Frozen at 0-degrees or below zero. "Food for Research or Evaluation Use". Sargento Technical Center, Elkhart Lake, WI 53020
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0753-2019·2019-01-02

    Sargento Recalls Frozen Unbreaded Egg and French Onion Samples for Contamination

    Sargento Foods is recalling specific frozen unbreaded egg and French onion samples due to potential Listeria monocytogenes or Salmonella contamination.

    Product
    Frozen Unbreaded Egg, 3 Cheese and caramelized onion. Sample Number 18-0115.01. Keep Frozen at 0-degrees or below zero. "Food for Research or Evaluation Use". Sargento Technical Center, Elkhart Lake, WI 53020
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0755-2019·2019-01-02

    Sargento Recalls Frozen Unbreaded Cheese Products for Listeria and Salmonella Risk

    Sargento Foods is recalling specific frozen unbreaded cheese products due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    Frozen Unbreaded French onion / Swiss and Onion CC. Sample Number 17-0160.01. Keep Frozen at 0-degrees or below zero. "Food for Research or Evaluation Use". Sargento Technical Center, Elkhart Lake, WI 53020
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0752-2019·2019-01-02

    Moonstruck Sea Salt Caramels Recalled for Undeclared Hazelnut Allergen

    Moonstruck Chocolate Company is recalling Sea Salt Caramels Tumbled in Milk Chocolate because the product may contain undeclared hazelnuts.

    Product
    Sea Salt Caramels Tumbled In Milk Chocolate, Moonstruck brand. The product sold in an individual resealable plastic bag, net wt. 4 oz. The product is number is 312235 and the UPC code is 7 11175 12235 9. The product also sold in cardboard box of 8/4 oz. bags. The box has
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-0682-2019·2019-01-02

    Radiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch

    Radiometer America Inc is recalling 2,131 ABL800 analyzers because software may cause a mismatch between patient demographics and test results.

    Product
    ABL800 analyzer, model numbers 393-800 and 393-801.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2019·2019-01-02

    RayStation Software Versions Recalled for Dose Tracking Coordinate Errors

    RaySearch Laboratories is recalling specific RayStation software versions because isocenter shifts in dose tracking are incorrectly interpreted.

    Product
    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0674-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK Testosterone Diagnostic Test Kits

    Tosoh Bioscience is voluntarily recalling ST AIA-PACK Testosterone kits due to a Class II defect. The recall covers 26,745 units distributed nationwide.

    Product
    ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0661-2019·2019-01-02

    ICU Medical Recalls Thermoset Room Temperature Injectate Delivery Systems

    ICU Medical is recalling 27,250 Thermoset Room Temperature Closed Loop Injectate Delivery Systems due to a defect in the thermoset check valve component that may cause leakage.

    Product
    Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0680-2019·2019-01-02

    Baxter Recalls GEM Coupler Forceps Due to Potential Rust

    Baxter Healthcare is recalling 123 GEM Coupler Forceps units because of potential rust on the devices. The recall covers nationwide and international distribution.

    Product
    GEM Coupler Forceps, GEM4183C, packaged individually.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0683-2019·2019-01-02

    Medtronic MiniMed Insulin Pumps Recalled for Missing Audio Alerts

    Medtronic is recalling specific MiniMed insulin pump models because software version 4.10 may fail to play expected audio sounds during alerts, alarms, or sirens.

    Product
    Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-0667-2019·2019-01-02

    Abbott Alinity i Estradiol Reagent Kit Recalled for Manufacturing Defect

    Abbott is recalling 79 units of Alinity i Estradiol Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.

    Product
    Alinity i Estradiol Reagent Kit, List Number 07P5020
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0670-2019·2019-01-02

    In2bones Recalls NeoSpan Compression Staple Kits Due to Incorrect Drill Bit Size

    In2bones USA, LLC is recalling NeoSpan SuperElastic Compression Staple kits because they contain a 3mm drill bit instead of the required 2mm bit.

    Product
    NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0665-2019·2019-01-02

    Abbott Alinity i Free T4 Reagent Kit Recalled for Manufacturing Defect

    Abbott is recalling 294 units of Alinity i Free T4 Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument loading failures.

    Product
    Alinity i Free T4 Reagent Kit, List Number 07P7030
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0344-2019·2019-01-02

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling specific lots of Temozolomide Capsules because they failed to meet dissolution specifications.

    Product
    Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0676-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK ACTH In Vitro Diagnostic Reagents

    Tosoh Bioscience Inc is voluntarily recalling 1,085 units of ST AIA-PACK ACTH in vitro diagnostic reagents distributed nationwide in the US.

    Product
    ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain dis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0669-2019·2019-01-02

    Abbott Alinity i 25-OH Vitamin D Reagent Kit Recall for Manufacturing Defect

    Abbott is recalling specific lots of Alinity i 25-OH Vitamin D Reagent Kits due to a manufacturing issue that may damage bottle necks and cause instrument failure.

    Product
    Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0675-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK Homocysteine Diagnostic Reagents

    Tosoh Bioscience is recalling 992 units of ST AIA-PACK Homocysteine reagents used for in vitro diagnostic testing. The voluntary recall covers all lots distributed nationwide.

    Product
    ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hype
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0666-2019·2019-01-02

    Abbott Recalls Alinity i Total Beta-hCG Reagent Kit Due to Manufacturing Defect

    Abbott is recalling 27 units of the Alinity i Total Beta-hCG Reagent Kit because a manufacturing issue may damage bottle necks, causing reagent loading failures on the instrument.

    Product
    Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0668-2019·2019-01-02

    Abbott Alinity i Progesterone Reagent Kit Recalled for Manufacturing Defect

    Abbott is recalling 157 units of Alinity i Progesterone Reagent Kits due to a manufacturing issue that can cause bottle neck damage and instrument failure.

    Product
    Alinity i Progesterone Reagent Kit, List Number 08P3620
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0685-2019·2019-01-02

    Hologic I-View Contrast Enhanced Digital Mammography System Recall

    Hologic is recalling 337 I-View Contrast Enhanced Digital Mammography systems due to a calibration issue that prevents visualization of contrast uptake.

    Product
    I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0660-2019·2019-01-02

    Randox SP CAL (LIQ) Calibrator Recall for Value Sheet Corrections

    Randox Laboratories is recalling SP CAL (LIQ) calibrators because value sheets were modified to improve alignment for specific assays.

    Product
    SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0664-2019·2019-01-02

    Abbott Alinity i TSH Reagent Kit Recalled for Manufacturing Defect

    Abbott is recalling Alinity i TSH Reagent Kits due to a manufacturing issue that may damage bottle necks, potentially causing reagent loading failures on the instrument.

    Product
    Alinity i TSH Reagent Kit, List Number 07P4830
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0671-2019·2019-01-02

    Tosoh AIA-PACK B12 Recalled Due to Potential Fluorescein Interference

    Tosoh Bioscience Inc is recalling AIA-PACK B12 reagents because fluorescein interference may cause inaccurately elevated Vitamin B12 test results.

    Product
    AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0345-2019·2019-01-02

    Amerigen Recalls Temozolomide Capsules for Failed Dissolution Specifications

    Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 180 mg, due to failed dissolution specifications. The FDA classified this as a Class III recall.

    Product
    Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
    Category
    Drug
    Distribution
    0 states

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