The Recall Desk

Archive

November 2018 recalls

846 recalls were announced in November 2018.

What the numbers show

Critical
142
Severe
250
High
301
Moderate
124
Low
29

Of the 846 recalls this month scored against our rubric, 17% are Critical, 30% are Severe.

401–500 of 846

  • LowFDA (Drugs)·D-0242-2019·2018-11-21

    Right Value Drug Stores Recalls Tadalafil SR 7 mg Capsules for Misbranding

    Right Value Drug Stores, Inc. is recalling Tadalafil SR 7 mg capsules due to misbranding. The affected lots were distributed in California.

    Product
    Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054. NDC 99999-9970-88
    Category
    Drug
    Distribution
    1 state
  • SevereCPSC·19036·2018-11-20

    Seabreeze Recalls Smart Thermaflo Bathroom Heater Fans Due to Fire Hazard

    Seabreeze International is recalling Smart Thermaflo Bathroom Heater Fans because the safety cutoff can fail, allowing the unit to overheat and catch fire.

    Product
    Smart Thermaflo Bathroom Heater Fans with nightlight
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·116-2018·2018-11-20

    Long Phung Recalls Pork Products Due to Possible Listeria Contamination

    Long Phung Food Products is recalling ready-to-eat pork products due to possible Listeria monocytogenes contamination linked to four confirmed illnesses.

    Product
    165368 C. Corporation — 165368 C. Corporation Recalls Pork Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V819000·2018-11-20

    Heartland Recalls 2019 Trailers Due to Bearing Grease Defect

    Heartland is recalling 2019 Pioneer and Prowler trailers because inner hub bearings may overheat and fail, increasing crash risk.

    Product
    HEARTLAND — HEARTLAND PIONEER, PROWLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V821000·2018-11-20

    Navistar Recalls 2019-2020 IC Bus CE School Buses for Brake Line Defect

    Navistar is recalling 187 IC Bus CE school buses from 2019-2020 because an improperly routed brake air line may kink, causing the vehicle to pull right or disabling anti-lock brakes.

    Product
    IC BUS — IC BUS CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V823000·2018-11-20

    Grand Design Recalls 2019 Imagine Trailers Due to Bearing Defect

    Grand Design is recalling 2019 Imagine recreational trailers because inner hub bearings may overheat and fail, increasing crash risk.

    Product
    GRAND DESIGN — GRAND DESIGN IMAGINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19718·2018-11-20

    HoMedics Recalls Giraffe Nightlights Due to Choking Hazard

    HoMedics is recalling MyBaby Giraffe Nightlights because small feet can detach, posing a choking hazard to small children.

    Product
    MyBaby Giraffe Nightlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V822000·2018-11-20

    RAM Recalls 2019 1500 Trucks for Passenger Seat Sensor Defect

    Chrysler is recalling 2019 RAM 1500 trucks because a loose passenger seat sensor may prevent proper airbag deployment, increasing injury risk in a crash.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V820000·2018-11-20

    Cruiser RV Recalls 2019 MPG and Radiance Ultra Lite Trailers

    Cruiser RV is recalling 2019 MPG and Radiance Ultra Lite trailers because inner hub bearings may overheat and fail, increasing crash risk.

    Product
    CRUISER RV — CRUISER RV RADIANCE ULTRA LITE, MPG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V818000·2018-11-19

    Audi Recalls Q5 and Q7 Models for Fuel Pump Flange Repair

    Volkswagen Group of America is recalling 2007-2012 Audi Q7 and 2009-2012 Audi Q5 vehicles to replace fuel pump flanges and install butyl tape to prevent fuel leaks and fire risk.

    Product
    AUDI — AUDI Q7, Q5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18T016000·2018-11-19

    Yokohama Recalls RY023 Tires Due to Tread Separation Risk

    Yokohama is recalling specific RY023 tires because the rubber compound may be incorrect, potentially causing the tread to separate from the casing and increasing the risk of a crash.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·115-2018·2018-11-19

    Deleite Foods Recalls Marinated Chicken Thigh Meat Due to Undeclared Allergens

    Deleite Foods Enterprises is recalling approximately 11,000 pounds of marinated raw chicken thigh meat because the labels fail to declare wheat and soy allergens.

    Product
    Deleite Foods Enterprises, Inc. Recalls Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·114-2018·2018-11-17

    Swift Beef Company Recalls Ground Beef Due to E. coli O157:H7

    Swift Beef Company is recalling approximately 99,260 pounds of raw ground beef products that may be contaminated with E. coli O157:H7. The products were distributed in California, Nevada, Oregon, Utah, and Washington.

    Product
    Swift Beef Company — Swift Beef Company Recalls Ground Beef Products due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    5 states
  • CriticalUSDA FSIS·113-2018·2018-11-16

    Majestic Meat Company Recalls Ground Beef for E. coli O157:H7

    Majestic Meat Company is recalling approximately 532 pounds of ground beef products in Utah due to possible E. coli O157:H7 contamination.

    Product
    Corfini Meat and Seafood — Majestic Meat Company Recalls Ground Beef Products due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V813000·2018-11-16

    ARBOC Transit Bus Recall for Foldaway Seat Locking Defect

    ARBOC is recalling 2015-2018 Spirit of Freedom, Mobility, and Independence buses because foldaway seat cushions may not stay locked during a crash.

    Product
    ARBOC — ARBOC, ARBOC SPECIALTY VEHICLES SPIRIT OF INDEPENDENCE, SPIRIT OF MOBILITY, SPIRIT OF FREEDOM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V815000·2018-11-16

    Autocar Recalls 2019 Xpeditor Vehicles Due to Steering Bracket Defect

    Autocar is recalling 761 2019 Xpeditor vehicles because the power steering assist cylinder bracket may not be properly secured, potentially causing a loss of steering ability.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18E105000·2018-11-16

    IMT Omnex Wireless Transmitters Recalled for Unintended Crane Movement

    Iowa Mold Tooling Co. is recalling Omnex Proportional Wireless Transmitters because a failing diode may cause cranes to move unexpectedly, increasing injury risk.

    Product
    ELECTRICAL SYSTEM recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V812000·2018-11-16

    Thor Motor Coach Recalls 2017-2019 Motorhomes for Windshield Shade Defect

    Thor Motor Coach is recalling 2017-2019 Challenger, Miramar, and Outlaw motorhomes because the driver's windshield roller shade may unroll unexpectedly, blocking visibility.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH MIRAMAR, CHALLENGER, OUTLAW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·19717·2018-11-15

    RH Recalls Metal-Wrapped Coffee Tables Due to Lead Exposure Risk

    Restoration Hardware is recalling specific metal-wrapped coffee tables because the metal tops may contain lead, posing a health risk to children.

    Product
    Metal-wrapped coffee tables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V810000·2018-11-15

    Mack Trucks Recalls 2019 Models Due to Tire Air Loss Risk

    Mack is recalling 818 2019 LR, Granite, and TerraPro trucks because specific Bridgestone tires may lose air rapidly, increasing crash risk.

    Product
    MACK — MACK LR, GRANITE (GR), TE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V808000·2018-11-15

    Wabash National Van Trailers Recalled for Detaching Limb Deflectors

    Wabash is recalling 2014-2019 Van trailers because limb deflectors may detach while moving, increasing crash risk. Dealers will remove the parts free of charge.

    Product
    WABASH NATIONAL — WABASH NATIONAL VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19716·2018-11-15

    LÍLLÉbaby Recalls Active Series Baby Carriers Due to Fall Hazard

    LÍLLÉbaby is recalling about 6,600 Active Series baby carriers because a sliding chest-clip strap can detach, posing a fall hazard to the child.

    Product
    Active Series baby carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·112-2018·2018-11-15

    Jennie-O Recalls Raw Ground Turkey Due to Salmonella Reading Contamination

    Jennie-O is recalling raw ground turkey products produced in September 2018 due to possible Salmonella Reading contamination linked to a multi-state outbreak.

    Product
    Jennie-O Turkey Store Sales, LLC Recalls Raw Ground Turkey Products due to Possible Salmonella Reading Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0251-2019·2018-11-14

    Native Remedies VertiFree Oral Spray Recalled for Microbial Contamination

    Silver Star Brands is recalling Native Remedies VertiFree Oral Spray due to microbial contamination. Consumers should stop using the product and return it to the point of purchase.

    Product
    Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·111-2018·2018-11-14

    Ron's Home Style Foods Recalls Chicken Salad Products Due to Listeria Risk

    Ron's Home Style Foods is recalling approximately 6,912 pounds of ready-to-eat chicken salad products in Texas due to possible Listeria monocytogenes contamination.

    Product
    Ron's Home Style Foods — Ron's Home Style Foods Recalls Ready to Eat Chicken Salad Products due to Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0254-2019·2018-11-14

    Silver Star Brands Recalls Native Remedies EyeClear Pro Oral Spray

    Silver Star Brands is recalling Native Remedies EyeClear Pro Oral Spray due to microbial contamination. Consumers should stop using the product and return it to the retailer.

    Product
    Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0432-2019·2018-11-14

    ARO Pistachios Recalls Pistachios Due to Salmonella Test Results

    ARO Pistachios, Inc. is recalling one lot of inshell pistachios after a customer test detected Salmonella.

    Product
    Inshell R/S 21/25 US-Select Pistachios NET WT. 25 lbs. 11.34 kg Product of the USA ARO Pistachio Inc. 19570 Avenue 88, Terra Bella, Ca 93270
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0253-2019·2018-11-14

    Silver Star Brands Recalls Native Remedies VaricoGo Oral Spray Due to Microbial Contamination

    Silver Star Brands is recalling 53 bottles of Native Remedies VaricoGo Oral Spray due to microbial contamination. The product was distributed nationwide in the United States.

    Product
    Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0269-2019·2018-11-14

    OriGen Reinforced Dual Lumen Cannula Recalled for Potential Tube Separation

    OriGen Biomedical is recalling 134 units of the VV19F Reinforced Dual Lumen Cannula because the extension tube may separate from the hub, posing a risk of blood loss.

    Product
    REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0216-2019·2018-11-14

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 2,580,448 bags of 0.9% Sodium Chloride Injection because they may leak and lack assurance of sterility.

    Product
    0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0229-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 25mg pellets because the company cannot assure the sterility of the product. The recall covers specific lots distributed nationwide.

    Product
    Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0255-2019·2018-11-14

    Silver Star Brands Recalls DizziFree Oral Spray Due to CGMP Deviations

    Silver Star Brands is recalling 247 bottles of Healthful Naturals DizziFree Oral Spray due to manufacturing deviations that could result in microbial contamination.

    Product
    Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling Estradiol 12.5mg pellets nationwide because the company cannot ensure the product is sterile.

    Product
    Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0227-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 15mg pellets because the company cannot ensure the products are sterile. The recall covers specific lots distributed nationwide.

    Product
    Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V805000·2018-11-14

    Ford Recalls 2018 Expedition and Lincoln Navigator for Seat Track Defect

    Ford is recalling 2018 Expedition and Lincoln Navigator vehicles because missing seat brackets may allow the second-row center seat to move in a crash, increasing injury risk.

    Product
    FORD — FORD, LINCOLN EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V802000·2018-11-14

    Ford Recalls 2019 Super Duty Trucks for Transmission Defect

    Ford is recalling 2019 F-250, F-350, and F-450 Super Duty trucks because an incorrect transmission casting may allow unintended vehicle movement.

    Product
    FORD — FORD F-250 SD, F-350 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0405-2019·2018-11-14

    Valley Processing Recalls Apple Juice Concentrate Due to Arsenic Levels

    Valley Processing Inc. is recalling specific lots of apple juice concentrate and organic apple juice concentrate because they contain high levels of inorganic arsenic.

    Product
    Apple juice concentrate and organic apple juice concentrate in 52 gallon drums, 5 gallon pails, 4 gallon pails, and 260 gallon totes
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0408-2019·2018-11-14

    NUTRANEXT Toxin Absorber Recalled for Elevated Lead Levels

    NUTRANEXT BUSINESS LLC is recalling Toxin Absorber with Organic Ginger Root packets because routine testing found elevated lead levels.

    Product
    Toxin Absorber with Organic Ginger Root - 14 packets and 30 packets
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0233-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 200mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0225-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 10mg pellets nationwide due to a lack of assurance of sterility. The affected lots have specific expiration dates.

    Product
    Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0398-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling 6,180 units of the RapidFlap SpinDown Clamp because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0252-2019·2018-11-14

    Silver Star Brands Recalls Native Remedies HypoSlim Oral Spray Due to Microbial Contamination

    Silver Star Brands is recalling 95 bottles of Native Remedies HypoSlim Oral Spray due to microbial contamination. The product was distributed nationwide in the US.

    Product
    Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0617-2019·2018-11-14

    Sam Dry Fruits Recalls Pistachios Due to Salmonella Risk

    Sam Dry Fruits and Enterprises Inc. is recalling 25 lb. bags of inshell pistachios because a positive Salmonella test was received during a supplier investigation.

    Product
    Inshell R/S 21/25 US- Select Pistachios; NET WT. 25 lb. (11.34kg) Product of the USA Production Date: 8/2018 ARO Pistachios Inc. 19750 Avenue 88, Terra Bella, CA 93270
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0230-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Qualgen, LLC is recalling Estradiol 6 mg pellets nationwide because the company cannot ensure the product is sterile.

    Product
    Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0215-2019·2018-11-14

    ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 5% Dextrose Injection bags because they may lack sterility and have the potential to leak.

    Product
    5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2019·2018-11-14

    Qualgen Testosterone and Anastrozole Pellets Recalled for Sterility Concerns

    Qualgen, LLC is recalling Testosterone 200 mg/Anastrozole 20 mg pellets due to a lack of assurance of sterility. The recall affects specific vial sizes distributed nationwide.

    Product
    Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0237-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 87.5mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0410-2019·2018-11-14

    Nutranext Recalls Colon Cleansing Kit Ginger Due to Lead Levels

    Nutranext Business LLC is recalling Colon Cleansing Kit Ginger products because routine testing found elevated lead levels that may pose health risks.

    Product
    Colon Cleansing Kit Ginger
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0362-2019·2018-11-14

    Tyson Recalls Pierre Philly Style Cheesesteak Sandwiches for Listeria and Salmonella

    Tyson Foods is recalling Pierre Philly Style Cheesesteak Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella.

    Product
    Pierre Philly Style Cheesesteak Sandwich, item 1125, 12 units packaged per case Net Wt. 4.65 LBS (2.11 kg) KEEP FROZEN
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0384-2019·2018-11-14

    Udi's Pesto Tortellini Recalled for Listeria and Salmonella Contamination

    Request Foods Incorporated is recalling Udi's Pesto Tortellini because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Udi's Pesto Tortellini 8 oz. UPC 98997 80974 Frozen 6, 8oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0391-2019·2018-11-14

    Oscor TB Series Bipolar Pacing Leads Recalled for Connector Sliding

    Oscor, Inc. is recalling TB Series Bipolar Pacing Leads because the connector cap housing may slide, potentially exposing the connection wire and causing loss of pacing.

    Product
    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0371-2019·2018-11-14

    Fred Meyer Recalls Mislabeled Cornbread Sold as Angel Food Cake Bar

    Fred Meyer Inc. is recalling 432 units of cornbread mislabeled as Angel Food Cake Bar due to undeclared milk and soy allergens.

    Product
    Product 8x8 " individually packaged in black plastic trays with clear plastic dome lid is cornbread and it was MIS-LABELED as Angel Food Cake Bar. The label of Angel Food Cake Bar has the UPC 111110-02100. The label is read in parts: "***Angel Food Cake Bar *** Net wt. 12
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0383-2019·2018-11-14

    Request Foods Recalls Evol Butternut Squash Lasagna Due to Contamination Risk

    Request Foods Incorporated is recalling Evol Butternut Squash Lasagna because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Evol Butternut Squash Lasagna 10.8oz. UPC 91627 00794 Frozen 8, 10.8oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0236-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 50mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2019·2018-11-14

    Roche CoaguChek XS Prothrombin Time Test Strips Recalled for High INR Results

    Roche Diagnostics is recalling CoaguChek XS Prothrombin Time test strips nationwide because they may produce abnormally high INR results.

    Product
    CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0235-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 37.5 mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0399-2019·2018-11-14

    Request Foods Recalls Tropical Bowl with Barramundi for Listeria and Salmonella Risk

    Request Foods Incorporated is recalling Love The Wild Hawaiian Style Tropical Bowl with Barramundi because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Love The Wild Hawaiian Style Tropical Bowl with Barramundi 9oz. UPC 50068 00602 Frozen 6, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2019·2018-11-14

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen, LLC is recalling Estradiol 18mg pellets because the company cannot assure the sterility of the product. The recall covers specific vial sizes distributed nationwide.

    Product
    Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error

    Zimmer Biomet is recalling 3,246 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2019·2018-11-14

    GE Healthcare Recalls Centricity Universal Viewer Due to Synchronization Failure

    GE Healthcare is recalling 73 Centricity Universal Viewer units because a synchronization failure may affect the display of medical images.

    Product
    Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0376-2019·2018-11-14

    Request Foods Recalls Evol Portabello Goat Cheese Ravioli for Contamination Risk

    Request Foods Incorporated is recalling Evol Portabello Goat Cheese Ravioli because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Evol Portabello Goat Cheese Ravioli 18oz UPC 91627 00789 Frozen 6, 18oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2019·2018-11-14

    BD Nexiva IV Catheter Recall Due to Needle Shield Failure

    Becton Dickinson is recalling 133,230 units of BD Nexiva Closed IV Catheter Systems because a needle shield defect may increase the risk of contaminated needlestick injuries.

    Product
    BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle shield
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0224-2019·2018-11-14

    Avella Recalls Bevacizumab Syringes Due to Sterility Assurance Concerns

    Avella of Deer Valley is recalling 911 pre-filled Bevacizumab syringes due to a lack of assurance of sterility. The product was distributed throughout the United States.

    Product
    BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-0396-2019·2018-11-14

    Jenny Craig Butternut Squash Ravioli Recalled for Listeria and Salmonella Risk

    Request Foods Incorporated is recalling Jenny Craig Butternut Squash Ravioli because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Jenny Craig Butternut Squash Ravioli 213g. UPC 55447 10625 Frozen 30, 213g. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0386-2019·2018-11-14

    Becton Dickinson Recalls PCEA ASV Yellow Microbore Administration Sets

    Becton Dickinson is recalling PCEA ASV Yellow Microbore administration sets because they may leak at the luer lock connection.

    Product
    PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2019·2018-11-14

    Becton Dickinson Recalls PCEA Administration Sets Due to Potential Leaks

    Becton Dickinson is recalling PCEA Administration Sets because they may leak at the connection point. The recall covers 566,737 units distributed worldwide.

    Product
    PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0407-2019·2018-11-14

    Bake One Recalls Pre Proof Danish Due to Plastic Contamination

    Bake One, Inc. is recalling Pre Proof Danish products because the firm found what appeared to be plastic in the product.

    Product
    Pre Proof Danish Net Wt: 13.7lbs (6.2Kg) Contains: Eggs, Milk, Soy and Wheat KEEP FROZEN AT 0 F OR BELOW Bake One, Inc. Smyrna, GA 30082 UPC 8 10509 01152 6
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0662-2019·2018-11-14

    Cereal Ingredients Inc. Recalls Gluten-Free Molasses Crunch Bites

    Cereal Ingredients Inc. is recalling 4,000 lbs of Flav-R-Bites Molasses Crunch because the product contains undeclared gluten.

    Product
    Flav-R-Bites -Molasses Crunch-, *Gluten Free, Cereal Ingredients Inc. Leavenworth, Kansas, packaged in 50 lb bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0393-2019·2018-11-14

    Request Foods Recalls Moe's Southwest Vegetarian Breakfast Bowls

    Request Foods Incorporated is recalling Moe's Southwest Vegetarian Breakfast Bowls due to possible contamination with Listeria monocytogenes and Salmonella.

    Product
    Moe's Southwest Vegetarian Breakfast Bowl 8oz. UPC 38000 17240 Frozen 8, 8oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0392-2019·2018-11-14

    Kashi Creamy Cashew Noodle Bowl Recalled for Listeria and Salmonella Risk

    Request Foods Incorporated is recalling Kashi Creamy Cashew Noodle Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Creamy Cashew Noodle Bowl 8oz. UPC 18627 10767 Frozen 8, 8oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2019·2018-11-14

    Zimmer Biomet RapidFlap SpinDown Clamp Recalled for Assembly Error

    Zimmer Biomet is recalling 23,726 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2019·2018-11-14

    Recall of Testosterone 12.5mg Pellet due to Sterility Concerns

    Qualgen, LLC is recalling Testosterone 12.5mg pellets nationwide because the sterility of the product cannot be assured. Consumers should stop using the affected lots and contact the manufacturer or pharmacist.

    Product
    Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0377-2019·2018-11-14

    Request Foods Recalls Evol Risotto for Listeria and Salmonella Contamination

    Request Foods Incorporated is recalling Evol Truffle Parmesan & Portabella Risotto because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Evol Truffle Parmesan & Portabella Risotto 18oz UPC 91627 00786 Frozen 6, 18oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0234-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 25 mg pellets nationwide because the company lacks assurance of sterility for these products.

    Product
    Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0370-2019·2018-11-14

    Village Baker Cinnamon Chip Sourdough Recalled for Undeclared Allergens

    Artisan Baking Company is recalling Village Baker Cinnamon Chip Sourdough because the label fails to declare milk powder and soy lecithin.

    Product
    Village Baker SPECIALTY ARTISAN BREADS CINNAMON CHIP SOURDOUGH. The product is whole sliced loaves packed in clear plastic bags that are closed with a twist tie. The net weight is 1.5 lbs. The loaves were sold as individual units. The UPC is 6 42739 00121 9. The product's la
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0378-2019·2018-11-14

    AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure

    AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 2x2 due to a potential pouch seal failure that could compromise sterility.

    Product
    Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0379-2019·2018-11-14

    AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure

    AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 4x5 due to a potential for pouch seal failure.

    Product
    Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0382-2019·2018-11-14

    Request Foods Recalls Udi's Broccoli & Kale Lasagna for Contamination Risk

    Request Foods Incorporated is recalling Udi's Broccoli & Kale Lasagna because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Udi's, Broccoli & Kale Lasagna 227g UPC 98997 80842 Frozen 6 units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0404-2019·2018-11-14

    Request Foods Recalls Vegetable Egg & Cheese Frittata for Listeria and Salmonella

    Request Foods Incorporated is recalling specific lots of Gordon Choice Vegetable Egg & Cheese Frittata due to possible contamination with Listeria monocytogenes and Salmonella.

    Product
    Gordon Choice / GFS Vegetable Egg & Cheese Frittata 60oz. UPC 93901 19112 Frozen 4 units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0385-2019·2018-11-14

    Request Foods Recalls Kashi Chimichurri Quinoa Bowls for Listeria and Salmonella

    Request Foods Incorporated is recalling Kashi Chimichurri Quinoa Bowls because ingredients were possibly contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi,Chimichurri Quinoa Bowl 9oz. UPC 18627 10440 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2019·2018-11-14

    Siemens Dimension Thermal Chamber Motor Cable Recall for Insulation Defect

    Siemens is recalling 277 Dimension thermal chamber motor cables worldwide due to single insulation instead of required double insulation, posing a potential electrical shock risk.

    Product
    Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 006304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2019·2018-11-14

    Medtronic CareLink 2090 Programmer Recalled for Software Vulnerability

    Medtronic is recalling CareLink 2090 Programmers worldwide due to a vulnerability that allows unauthorized software updates during the SDN download process.

    Product
    Medtronic CareLink 2090 Programmer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0408-2019·2018-11-14

    Accuray Recalls CyberKnife M6 Systems Due to Wrist Component Failure Risk

    Accuray is recalling 93 CyberKnife M6 systems worldwide due to manufacturing variations in the robot wrist that may cause premature component failure.

    Product
    CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0231-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 100mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0366-2019·2018-11-14

    Tropical Dreams Ice Cream Recalled for Undeclared Soy and Coconut Allergens

    Edney and Sellers, Ltd. is recalling Tropical Dreams Super Premium Ice Cream in Hawaii because soy oil and coconut were not declared on the label.

    Product
    Tropical Dreams Super Premium Ice Cream Chocolate Coconut Macadamia Nut; Pint container; UPC 7 18122 41477 2 Ingredients: Cream, Sugar, Skim milk powder, water, cocoa powder, dark chocolate, pure vanilla, macadamia nuts, corn syrup, barley malt, carob bean gum and guar gum (s
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0373-2019·2018-11-14

    Howmedica Recalls 15 Pouches of Sterile Knee Instruments Due to Barrier Risk

    Howmedica Osteonics Corp. is recalling 15 pouches of sterile knee instruments because the outer sterile barrier may be compromised.

    Product
    Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0401-2019·2018-11-14

    Request Foods Recalls Beecher's Enchilada Bowls Due to Contamination Risk

    Request Foods Incorporated is recalling Beecher's Enchilada Bowl Blanco frozen units because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Beecher's Enchilada Bowl Blanco 9oz. UPC 82045 11381 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0402-2019·2018-11-14

    Request Foods Recalls Beecher's Enchilada Bowls for Listeria and Salmonella

    Request Foods Incorporated is recalling Beecher's Enchilada Bowl Rojo due to potential contamination with Listeria monocytogenes and Salmonella.

    Product
    Beecher's Enchilada Bowl Rojo 9oz. UPC 82045 11380 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide

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