The Recall Desk

Archive

May 2019 recalls

587 recalls were announced in May 2019.

What the numbers show

Critical
22
Severe
152
High
209
Moderate
184
Low
20

Of the 587 recalls this month scored against our rubric, 4% are Critical, 26% are Severe.

301–400 of 587

  • ModerateFDA (Drugs)·D-1305-2019·2019-05-22

    DrKids Nasal Saline Vials Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Himasal Natural Nasal Saline Solution vials due to potential contamination with B. cepacia bacteria.

    Product
    DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1344-2019·2019-05-22

    Healthy Life Snacks Tropical Trail Mix Recalled for Undeclared Sulfur Dioxide

    Healthy Life Snacks is recalling Tropical Trail Mix because it contains undeclared sulfur dioxide. The product was distributed in Massachusetts and Rhode Island.

    Product
    Healthy Life Snacks- Tropical Trail Mix 4 oz Polypropylene bag UPC code 2362918909
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1351-2019·2019-05-22

    Back Roads Granola Recalled for Potential Aluminum Contamination

    Back Roads Food Company is recalling Dark Chocolate Pecan Granola because it may contain pieces of aluminum.

    Product
    Back Roads Granola: Dark Chocolate Pecan Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1316-2019·2019-05-22

    Abbott Alinity ci-series System Control Module Software Recall

    Abbott is recalling Alinity ci-series System Control Module software version 2.5.1 due to potential performance issues.

    Product
    Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Food)·F-1367-2019·2019-05-22

    Barlean's Omega Man Softgels Recalled for Undeclared Sulfites

    Barlean's LLC is recalling Omega Man softgels due to undeclared sulfites. Sulfite levels do not exceed 10 ppm.

    Product
    Item FG 10149, Barlean s, Omega Man, 120 Softgels per bottle, UPC 7 05875 10019 9
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1346-2019·2019-05-22

    MediPress Pneumatic Compression System Recalled for Lack of Clearance

    Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.

    Product
    MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
    Category
    Medical Device
    Distribution
    36 states
  • LowFDA (Devices)·Z-1356-2019·2019-05-22

    Abbott Recalls ARCHITECT HbA1C Calibrators Shipped Without Dry Ice

    Abbott Laboratories is recalling ARCHITECT HbA1C Calibrators in Latvia because they were delivered without the required dry ice.

    Product
    ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1358-2019·2019-05-22

    Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Missing Dry Ice

    Abbott Laboratories is recalling two units of ARCHITECT Intact PTH Calibrators because they were delivered without the required dry ice.

    Product
    ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1357-2019·2019-05-22

    Abbott Recalls ARCHITECT Intact PTH Controls Due to Missing Dry Ice

    Abbott Laboratories is recalling ARCHITECT Intact PTH Controls because they were delivered without required dry ice. The recall affects units distributed to Latvia.

    Product
    ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1355-2019·2019-05-22

    Abbott Recalls ARCHITECT Sirolimus Calibrators Shipped Without Dry Ice

    Abbott Laboratories is recalling ARCHITECT Sirolimus Calibrators in Latvia because they were delivered without the required dry ice.

    Product
    ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1359-2019·2019-05-22

    Abbott Troponin-I Controls Recalled for Missing Dry Ice

    Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Controls delivered without required dry ice to Latvia.

    Product
    ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when use
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1362-2019·2019-05-22

    Abbott Multichem S Plus Quality Control Serum Recalled for Missing Dry Ice

    Abbott Laboratories is recalling Technopath Multichem S Plus Level 1 quality control serum because units were delivered without required dry ice.

    Product
    Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1363-2019·2019-05-22

    Abbott Technopath Multichem S Plus Level 2 Recalled for Missing Dry Ice

    Abbott Laboratories is recalling Technopath Multichem S Plus Level 2 quality control serum delivered to Latvia without required dry ice.

    Product
    Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1360-2019·2019-05-22

    Abbott Troponin-I Calibrators Recalled for Missing Dry Ice Packaging

    Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Calibrators because they were delivered without the required dry ice.

    Product
    ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1361-2019·2019-05-22

    Abbott Recalls Alinity i Anti-TPO Calibrators Due to Missing Dry Ice

    Abbott Laboratories is recalling Alinity i Anti-TPO Calibrators in Latvia because they were delivered without required dry ice.

    Product
    ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·19V383000·2019-05-21

    Honda Recalls 2019 CR-V Vehicles for Steering Wheel Air Bag Defect

    Honda is recalling 2019 CR-V vehicles because burrs on the steering wheel core may damage air bag wiring, potentially disabling the driver's air bag or causing it to deploy unexpectedly.

    Product
    HONDA — HONDA CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·056-2019·2019-05-21

    BEF Foods Recalls Bob Evans Beef Stroganoff Pasta Produced Without Inspection

    BEF Foods is recalling approximately 527 pounds of Bob Evans Beef Stroganoff Pasta produced without federal inspection. No adverse reactions have been reported.

    Product
    BEF Foods, Inc. — BEF Foods, Inc. Recalls Beef Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    7 states
  • SevereCPSC·19124·2019-05-21

    ION Audio Recalls Portable Speakers Due to Explosion Hazard

    ION Audio is recalling four models of portable speakers because hydrogen gas can leak from the battery, causing the speaker to burst and explode.

    Product
    Portable speakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V381000·2019-05-20

    Newmar Recalls 2019-2020 Motorhomes Due to Brake Valve Defect

    Newmar is recalling 40 specific 2019 and 2020 motorhomes because a brake relay valve defect may cause extended stopping distances, increasing crash risk.

    Product
    NEWMAR — NEWMAR KING AIRE, LONDON AIRE, ESSEX, DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V382000·2019-05-20

    Ducati Recalls Panigale Motorcycles Due to Fuel Tank Pressure Issue

    Ducati is recalling 2018-2019 Panigale motorcycles because excessive fuel tank pressure may cause fuel to spray when opening the cap, increasing injury and fire risks.

    Product
    DUCATI — DUCATI PANIGALE SPECIALE, PANIGALE V4 S, PANIGALE V4, PANIGALE R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V380000·2019-05-19

    Heil AJB9-1040 Hybrid Trailers Recalled for Frame Cracking

    Entrans is recalling 2017-2020 Heil AJB9-1040 Hybrid trailers because frame cracks may develop, affecting handling and increasing crash risk.

    Product
    HEIL — HEIL AJB9-1040 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·055-2019·2019-05-18

    Vienna Beef Recalls Frankfurters Due to Possible Metal Contamination

    Vienna Beef Ltd. is recalling approximately 2,030 pounds of beef frank links that may contain metal. The products were shipped to food service locations in Illinois, Indiana, and Wisconsin.

    Product
    Vienna Beef Ltd. — Vienna Beef Ltd. Recalls Beef Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • SevereUSDA FSIS·054-2019·2019-05-17

    Caito Foods Recalls Chicken Salads Due to Undeclared Soy Allergen

    Caito Foods LLC is recalling approximately 1,767 pounds of ready-to-eat chicken salads because they contain undeclared soy, a known allergen.

    Product
    Caito Foods, LLC — Caito Foods LLC. Recalls Salads with Chicken Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·19V379000·2019-05-17

    Newell Recalls 2017-2020 P50 Motorcoaches Due to Wiper Linkage Defect

    Newell Coach Corp. is recalling 2017-2020 P50 motorcoaches because a short wiper arm linkage may cause the wiper to rotate downward, reducing visibility and increasing crash risk.

    Product
    NEWELL — NEWELL P50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V376000·2019-05-16

    Micro Bird Recalls 2018-2019 School Buses for Solenoid Overheating Risk

    Micro Bird is recalling 2018-2019 G5 and T-Series school buses because a heavy-duty solenoid may overheat nearby components, potentially causing vehicle stoppage or fire.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES SCHOOL BUS, G5 TRANSIT BUS, G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V378000·2019-05-16

    Honda and Acura Recall Vehicles Due to Passenger Air Bag Defect

    Honda is recalling 19,138 vehicles because the front passenger air bag inflator may be installed incorrectly, potentially preventing proper deployment in a crash.

    Product
    HONDA — HONDA, ACURA INSIGHT, CIVIC, ACCORD CROSSTOUR, CIVIC GX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1277-2019·2019-05-15

    Alvogen Recalls Fentanyl Transdermal Systems Due to Product Mix-Up

    Alvogen is recalling Fentanyl Transdermal Systems because a customer reported a carton labeled 12 mcg/h contained 50 mcg/h patches.

    Product
    FENTANYL SYSTEM — FENTANYL SYSTEM (FENTANYL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1338-2019·2019-05-15

    Caito Foods Recalls Fresh Cut Melons for Salmonella Carrau Risk

    Caito Foods LLC is recalling fresh cut watermelon, honeydew, cantaloupe, and mixed fruit due to potential Salmonella Carrau contamination.

    Product
    Fresh cut watermelon, fresh cut honeydew melon, fresh cut cantaloupe and fresh cut mixed fruit containing one of these melons.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1328-2019·2019-05-15

    Oregon's Wild Harvest Recalls Dried Elderberry for Glass Contamination

    Oregon's Wild Harvest is recalling dried whole elderberry products due to glass fragment contamination. The recall affects 4 oz and 1 lb bags distributed in 23 states.

    Product
    Dried whole elderberry, Oregon s Wild Harvest brand, packaged in metalized plastic bag, net wt. 4 oz or 1 lb. Each case contains 12 bags. Item # for 4 oz. is 15352. UPC of 4 oz. bag is 7 06195 05352 3. Item # for 1 lb. is 11352. UPC of 1 lb. bag is 7 06195 01352 7. T
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Drugs)·D-1274-2019·2019-05-15

    Sagent Recalls Ketorolac Tromethamine Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling 75,825 vials of Ketorolac Tromethamine Injection because microbial growth was detected during a routine manufacturing simulation.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1272-2019·2019-05-15

    Zydus Recalls Acyclovir Tablets Due to Labeling Error with Carvedilol

    Zydus Pharmaceuticals is recalling Acyclovir 400 mg tablets because one bottle was found to contain Carvedilol 6.25 mg tablets due to a label mix-up.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1273-2019·2019-05-15

    Zydus Recalls Carvedilol Tablets Due to Labeling Mix-Up

    Zydus Pharmaceuticals is recalling Carvedilol 6.25 mg tablets because one bottle was found labeled as Acyclovir 400 mg.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·052-2019·2019-05-15

    Crab House Trading Recalls Frozen Yellow Walking Fish

    Crab House Trading Corp. is recalling approximately 49,000 pounds of frozen yellow walking fish produced without federal inspection.

    Product
    Crab House Trading Corp. Recalls Siluriformes Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1296-2019·2019-05-15

    Abbott ARCHITECT cSystems ICT Module Recall for False Chloride Results

    Abbott is recalling ARCHITECT cSystems ICT Modules due to a potential for falsely elevated serum or plasma chloride results.

    Product
    Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V373000·2019-05-15

    Navistar Recalls IC Bus School Buses Due to Rear Brake Drag

    Navistar is recalling 2016-2020 IC Bus school buses because the driver-side rear brakes may drag, potentially causing fire or injury.

    Product
    IC BUS — IC BUS RECB, CE, CESB, RESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V374000·2019-05-15

    Navistar Recalls 2017 IC CE Transit Buses for Brake Drag

    Navistar is recalling 2017 IC CE transit buses because the driver-side rear brakes may drag, posing a fire and injury risk.

    Product
    IC BUS — IC BUS CESB, CE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1331-2019·2019-05-15

    Laduree Frozen Poppy Seed Bread Recalled for Elevated Morphine and Codeine

    Laduree USA is recalling frozen poppy seed bread containing elevated levels of morphine and codeine. The product was distributed to warehouses and restaurants in Washington DC and New York.

    Product
    Frozen Poppy Seed Bread (57 grams), UPC Codes: (01)03556420003673(15)191122(10)181122(91)0937326, Lot 22112018
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1302-2019·2019-05-15

    Zimmer Biomet Recalls T7 Driver Cannulated AO Due to Fracture Risk

    Zimmer Biomet is recalling 5,885 T7 Driver Cannulated AO units because they may fracture, bend, or shear during use.

    Product
    T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and ph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1336-2019·2019-05-15

    Lee's Tea Pink Chai Loose Leaf Tea Recalled for Salmonella Contamination

    Lee's Provisions Inc. is recalling Pink Chai Organic Spiced Tulsi Tea due to potential Salmonella contamination. Consumers should stop using the product.

    Product
    Lee's Tea brand of Pink Chai - Organic Spiced Tulsi Tea Blend Loose Leaf Tea packaged in re-sealable plastic pouches sizes 30g, UPC 6 28055 21014 6 and 90g, UPC 6 28055 21004 7.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1295-2019·2019-05-15

    Siemens Cios Alpha C-arm X-ray System Recalled for Component Wear

    Siemens is recalling two Cios Alpha mobile X-ray systems because continuous high-output operation may cause premature failure of radiation components.

    Product
    Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    ConMed is recalling Anchor Tissue Retrieval Systems because voids or partial seals may compromise sterility. The recall covers units distributed worldwide.

    Product
    ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1329-2019·2019-05-15

    Bornstein Seafoods Recalls Fresh Cooked Pink Shrimp Meat Due to Glass Contamination

    Bornstein Seafoods Inc is recalling 440 lbs of Fresh Cooked Pink Shrimp Meat in Oregon due to glass fragment contamination.

    Product
    Fresh Cooked Pink Shrimp Meat, refrigerated, packaged in 5 pound plastic tubs with a label sticker on the lid. Master carton is cardboard Bornstein Box. The label is read in parts: "***WILD OREGON FRESH COOKED Shrimp Meat ***KEEP REFRIGERATED*** NET WT 5 lb ***Ingredients: Shr
    Category
    Food
    Distribution
    1 state
  • HighCPSC·19120·2019-05-15

    Hush Recalls Anesthetic Gels and Sprays for Child-Resistant Packaging Failure

    Hush is recalling anesthetic gels, sprays, and foam soaps because the packaging does not meet child-resistant closure requirements, posing a risk of poisoning to young children.

    Product
    Hush gels, sprays and Hush foam soaps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    ConMed is recalling Anchor Tissue Retrieval Systems because voids or partial seals may compromise the sterility of the product.

    Product
    ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    Conmed Corporation is recalling the Anchor Tissue Retrieval System due to seal defects that may compromise sterility.

    Product
    ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2019·2019-05-15

    Zimmer Biomet Recalls T7 Driver Solid AO Due to Fracture Risk

    Zimmer Biomet is recalling 1,924 T7 Driver Solid AO units because they may fracture, bend, or shear during use.

    Product
    T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalang
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1346-2019·2019-05-15

    El Guapo Chile Pods Recalled for Unlabeled Peanut Allergen

    Mojave Foods is recalling El Guapo Chile Pods due to an unlabeled peanut allergen. Consumers should check their pantry for the affected sizes and UPC codes.

    Product
    El Guapo Pasilla-Ancho Chile Pods 2oz, 7.5oz, 11oz
    Category
    Food
    Distribution
    28 states
  • HighFDA (Food)·F-1330-2019·2019-05-15

    Elite Spice Recalls Basil Olive Oil Tortilla Seasoning for Undeclared Milk

    Elite Spice Inc. is recalling Basil Olive Oil Flavored Tortilla Seasoning because it contains an undeclared milk allergen.

    Product
    Basil Olive Oil Flavored Tortilla Seasoning Package Type: Box with liner, Units Per Case: 1, Weight Per Package: 50 pounds
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1309-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    Conmed Corporation is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall affects 7,930 units distributed in the US and 13 other countries.

    Product
    ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity duri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·053-2019·2019-05-15

    MIBO Fresh Foods Recalls Chef Salads Due to Undeclared Anchovies

    MIBO Fresh Foods LLC is recalling approximately 1,460 pounds of H.E.B. Chef Salads because the products contain anchovies, a known allergen, that is not declared on the label.

    Product
    MIBO Fresh Foods LLC — MIBO Fresh Foods LLC Recalls Salad with Meat Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1216-2019·2019-05-15

    Alpha Omega Engineering Recalls Neuro Omega Systems Due to Tissue Harm Risk

    Alpha Omega Engineering is recalling 29 Neuro Omega Systems because improperly connected cables may cause high charge density, leading to tissue harm.

    Product
    Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Sterility Seal Defects

    ConMed is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall covers 5,034 units distributed worldwide.

    Product
    ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19122·2019-05-15

    Beaba Recalls Babycook Neo Steam Cookers Due to Glass Bowl Laceration Hazard

    Beaba is recalling Babycook Neo steam cooker/blenders because the glass bowl can shatter, posing a laceration hazard. Consumers should stop using the product and contact Beaba for a free replacement.

    Product
    Babycook Neo steam cooker/blenders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1282-2019·2019-05-15

    Medtronic Guardian Connect App Recalled for Silent Operating System Shutdowns

    Medtronic is recalling the Guardian Connect App because the operating system may close it without warning, preventing users from receiving critical blood glucose alerts.

    Product
    Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1285-2019·2019-05-15

    Cardinal Health Recalls ChemoPlus Goggles Due to Latex Mislabeling

    Cardinal Health is recalling ChemoPlus Protective Wrap-around Goggles because the kit labels state they are latex-free, but the goggle straps contain natural rubber latex.

    Product
    ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2019·2019-05-15

    Cardinal Health Recalls ChemoPlus Chemo Spill Kits Due to Latex

    Cardinal Health 200, LLC is recalling ChemoPlus Chemo Spill Kits because the safety goggles inside contain natural rubber latex, despite the kit label stating the product is latex-free.

    Product
    ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    Conmed Corporation is recalling specific lots of the Anchor Tissue Retrieval System because seal defects may compromise the product's sterility.

    Product
    ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1299-2019·2019-05-15

    Siemens Atellica IM 1300 Analyzer Recalled for Software Issues

    Siemens Healthcare Diagnostics is recalling 277 Atellica IM 1300 Analyzers due to multiple issues identified in the system software that required an update.

    Product
    Atellica IM 1300 Analyzer, Material Number 11066001
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1288-2019·2019-05-15

    Ortho-Clinical VITROS 5600 Systems Recalled for Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1293-2019·2019-05-15

    Ortho-Clinical VITROS ECi Immunodiagnostic System Recalled for Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 25 refurbished VITROS ECi Immunodiagnostic Systems because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1292-2019·2019-05-15

    Ortho-Clinical VITROS ECi/ECiQ Immunodiagnostic System Recalled for Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 45 VITROS ECi/ECiQ Immunodiagnostic Systems worldwide due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1337-2019·2019-05-15

    U.S. Tov Recalls Dragonfly Dehydrated Guava for Undeclared Sulfites

    U.S. Tov, Inc. is voluntarily recalling 68 units of Dragonfly Dehydrated Guava because the product contains undeclared sulfites.

    Product
    Dragonfly Dehydrate Guava Ing: Guava, Sugar, Salt Net Wt: 5.25 ozs 150g Distributed by: U.S. Trading Company Product of Thailand Item Number:37115 UPC: 721557371152
    Category
    Food
    Distribution
    27 states
  • ModerateFDA (Food)·F-1333-2019·2019-05-15

    Le Cafe de la Plage Recalls Black Vanilla Ice Cream Due to Plastic Pieces

    Le Cafe de la Plage is recalling 320 pints of Malibu Black Vanilla ice cream in California due to two complaints of plastic pieces in the product.

    Product
    Le Cafe de la Plage Malibu Black Vanilla; Hand-Crafted Ice Cream 1 Pint PETE plastic twist top container:
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1290-2019·2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunoassay Systems Due to Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 28 VITROS 3600 Immunoassay Systems because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1327-2019·2019-05-15

    Wegmans Cilantro Lime Green Sauce Recalled for Foreign Material

    Wegmans is recalling Cilantro Lime Green Sauce in 8 oz and 0.5 gallon containers due to potential foreign material contamination.

    Product
    Wegmans Food You Feel Good About Cilantro Lime Green Sauce. A finishing sauce for meats, seafood & Veggies in 8 oz. plastic containers or .5 gallon bulk plastic containers.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1334-2019·2019-05-15

    Schreiber Foods Recalls Colby and Monterey Jack Cheese for Foreign Material

    Schreiber Foods is recalling specific brands of Colby and Monterey Jack cheese due to the presence of hard plastic foreign material.

    Product
    Shredded and blocks of Colby & Monterey Jack cheese - Labeled and Packaged: 1) Great Value, Finely Shredded, Colby & Monterey Jack Cheese, Net Wt 8 oz; packaged in plastic pouches, 12 per case; 2) Great Value, Finely Shredded, Colby & Monterey Jack Cheese, Net Wt 16 oz; pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-1332-2019·2019-05-15

    Island Desserts Recalls Key Lime Torte for Undeclared Food Dyes

    Island Desserts LLC is recalling 810 Key Lime and Cream Tortes because they contain undeclared FD&C Colors Yellow #5 and Blue #1.

    Product
    Key Lime and Cream Torte, 5 oz., Keep in Freezer for up to 6 months or refrigerated for 5 days
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1335-2019·2019-05-15

    Schreiber Foods Recalls Great Value Fiesta Blend Cheese Due to Plastic

    Schreiber Foods is recalling Great Value Fiesta Blend Cheese because it may contain hard plastic. The product was distributed to grocery stores in 30 states.

    Product
    Great Value, Finely Shredded, Fiesta Blend Cheese, Shredded Monterey Jack, Cheddar, Queso Quesadilla and Asadero Cheeses, Net Wt 8 oz; packaged in plastic pouches, 12 per case;
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1283-2019·2019-05-15

    Cardinal Health Recalls ChemoPlus Spill Kits Due to Latex Mismatch

    Cardinal Health is recalling ChemoPlus chemotherapy spill kits because the safety goggles inside contain natural rubber latex, despite the kit label stating the product is latex-free.

    Product
    ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1294-2019·2019-05-15

    Medica Wash1 Solution Recalled for Ineffective Probe Cleaning

    Medica Corporation is recalling Wash1 solution because it fails to clean the probe effectively, potentially causing test interference on the EasyRA analyzer.

    Product
    Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1301-2019·2019-05-15

    Siemens Atellica Sample Handler Prime Recalled for Software Issues

    Siemens Healthcare Diagnostics is recalling 474 Atellica Sample Handler Prime units due to multiple issues identified in the system software that required an update.

    Product
    Atellica Sample Handler Prime, Material Number 11069001
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1297-2019·2019-05-15

    Elekta Unity Systems Recalled for Missing Contrast Agent Warnings

    Elekta Limited is recalling nine Elekta Unity systems because the user manual lacks a warning regarding the administration of unvalidated contrast agents.

    Product
    Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in acco
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1289-2019·2019-05-15

    Ortho-Clinical VITROS 3600 Immunoassay System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunoassay System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1287-2019·2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1300-2019·2019-05-15

    Siemens Atellica IM 1600 Analyzer Recalled for Software Issues

    Siemens Healthcare Diagnostics is recalling 366 Atellica IM 1600 Analyzers due to multiple issues identified in the system software that required an update.

    Product
    Atellica IM 1600 Analyzer, Material Number 11066000
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1291-2019·2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 62 VITROS XT 7600 Integrated Systems worldwide because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2019·2019-05-15

    Cardinal Health Recalls ChemoPlus Spill Kits Due to Latex Inconsistency

    Cardinal Health is recalling ChemoPlus chemotherapy spill kits because the safety goggles inside contain natural rubber latex, despite the kit label stating the product is latex-free.

    Product
    ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1298-2019·2019-05-15

    Siemens Cios Alpha Mobile X-ray System Recalled for Component Wear

    Siemens is recalling 257 Cios Alpha mobile X-ray systems because continuous high-output use may cause premature failure of radiation components.

    Product
    Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V367000·2019-05-14

    Daimler Trucks Recalls 2019 Freightliner and Western Star Trucks for Brake Bolt Issue

    Daimler Trucks North America is recalling 253 specific 2019 heavy-duty trucks because brake caliper mounting bolts may be insufficiently tightened, potentially reducing brake effectiveness.

    Product
    FCCC — FCCC, FREIGHTLINER, WESTERN STAR XCL, XCS, CASCADIA, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V371000·2019-05-14

    Daimler Trucks Recalls MT55 and MT45 Chassis for Brake Pedal Defect

    Daimler Trucks North America is recalling 2012-2019 Freightliner Custom Chassis MT55 and MT45 vehicles because a brake pedal clip may detach, causing brake light failure or pedal detachment.

    Product
    FCCC — FCCC MT55, MT45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V370000·2019-05-14

    Daimler Trucks Recalls 741 Vehicles for Insufficient Brake Air Reservoir Capacity

    Daimler Trucks North America is recalling 741 Freightliner, Sterling, and Western Star trucks because insufficient air reservoir capacity may reduce brake effectiveness and increase crash risk.

    Product
    STERLING — STERLING, FREIGHTLINER, WESTERN STAR ACTERRA, LT9500, L8500, CLASSIC XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V368000·2019-05-14

    2019 Thomas Built Buses Saf-T-Liner C2 Brake Recall

    Daimler Trucks North America is recalling 2019 Thomas Built Buses Saf-T-Liner C2 vehicles because loose brake caliper bolts may reduce braking effectiveness.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·051-2019·2019-05-14

    Taylor Farms Recalls Chicken Caesar Salad Due to Undeclared Anchovies

    Taylor Farms Texas Inc. is recalling 1,079 pounds of Caesar salad with chicken because the product contains anchovies, a known allergen, that are not listed on the label.

    Product
    Taylor Farms TX, Inc. — Taylor Farms Texas Inc. Recalls Salad with Chicken Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·19V363000·2019-05-14

    Mazda Recalls 2019 Mazda3 Vehicles for Incorrect Air Bag Indicator Light

    Mazda is recalling 2019 Mazda3 vehicles because the passenger air bag deactivation indicator light may turn off incorrectly, potentially leaving occupants unaware of safety system status.

    Product
    MAZDA — MAZDA MAZDA3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V364000·2019-05-13

    LDJ Recalls 2019 Thunder Creek Trailers Due to Wheel Lug Nut Issues

    LDJ Manufacturing is recalling 102 2019 Thunder Creek trailers because wheel lug nuts may loosen, potentially causing a wheel to separate and increasing crash risk.

    Product
    THUNDER CREEK — THUNDER CREEK FST, EV, SLT, MTT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V361000·2019-05-13

    Trail King Recalls 2016-2019 TKT50 Trailers Due to Missing Brake Line

    Trail King is recalling 2016-2019 TKT50 trailers because a missing air control line may prevent service brakes from applying on some axles, increasing crash risk.

    Product
    TRAIL KING — TRAIL KING TILT TRAILER (TKT)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V362000·2019-05-13

    Ford Recalls 2013-2016 Fusion Vehicles for Transmission Shifter Cable Bushing Defect

    Ford is recalling 2013-2016 Fusion vehicles with 2.5-liter engines because a transmission shifter cable bushing may degrade and detach. This could allow the driver to exit the vehicle while the transmission is not in Park, increasing crash risk.

    Product
    FORD — FORD FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V360000·2019-05-13

    Spartan Emergency Chassis Recalled for Brake Valve Defect

    Spartan Motors is recalling 2018-2020 emergency response and motor home chassis because a brake relay valve defect may increase stopping distance.

    Product
    SPARTAN — SPARTAN K3, K2, K4, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V357000·2019-05-13

    Lance Camper Recalls 2019-2020 Truck Campers Due to Bunk Bed Gap

    Lance Camper is recalling 2019-2020 855S and 1172 Truck Campers because a gap in the fold-down bunk bed may allow occupants to fall and get stuck.

    Product
    LANCE CAMPER — LANCE CAMPER TRUCK CAMPER (855S), TRUCK CAMPER (1172)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V359000·2019-05-13

    Unruh Fire Recalls One 2018 RAM 5500 Fire Truck for Brake Light Defect

    Unruh Fire is recalling one 2018 RAM 5500-based fire truck because its brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    RAM — RAM 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide

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