The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

24276–24300 of 50442

  • HighFDA (Devices)·Z-0604-2020·2019-12-11

    Steris Eagle 3000 Sterilizer Recall Due to Incorrect Safety Valve

    Steris is recalling 236 Eagle 3000 Small Steam Sterilizers because the preventive maintenance kit may contain an incorrect pressure safety valve.

    Product
    Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gravity designed for sterilization of non-porous, heat- and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0560-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl 250 mcg/5 mL syringes due to the presence of glass particulate matter. The recall is nationwide.

    Product
    fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0548-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the presence of particulate matter, including potential glass particles.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·20039·2019-12-11

    Profile Design Recalls Carbon Aerobars Due to Crash Hazard

    Profile Design is recalling Aeria Ultimate carbon aerobars because they can crack and break, causing riders to lose control and crash.

    Product
    Aeria Ultimate carbon aerobars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0557-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter

    QuVa Pharma is recalling fentanyl and bupivacaine injection products due to the presence of particulate matter, specifically potential glass particles.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·19V882000·2019-12-11

    Indian Recalls 2019 Motorcycles Due to Defective Circuit Breaker

    Indian Motorcycle is recalling 5,474 2019 models because a defective circuit breaker may cause sudden engine stalls, increasing crash risk.

    Product
    INDIAN — INDIAN CHIEFTAIN, ROADMASTER, SPRINGFIELD, SPRINGFIELD DARK HORSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0447-2020·2019-12-11

    Northern Fisheries Recalls Tuna Products Due to Elevated Histamine Levels

    Northern Fisheries Ltd. is voluntarily recalling specific tuna products due to potentially elevated histamine levels. The recall covers Tuna Saku, tuna medallions, and tuna steaks.

    Product
    Tuna King Tuna Saku 12-16oz 1x10lb Production date 06/13/2019 Expiration: 06/13/2021 UPC: 815838022267 Lot: 0058801
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0533-2020·2019-12-11

    Fagron Recalls LETS GEL Kits Due to Microbial Contamination

    Fagron, Inc. is recalling 11,912 kits of LETS GEL Convenience Packs due to microbial contamination of the non-sterile product.

    Product
    LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0205-2020·2019-12-11

    Amazon Recalls Vegan Hummus Dip Due to Listeria Risk

    Amazon is recalling 491 units of Go Vegan Hummus Veggies in Washington due to potential Listeria monocytogenes contamination.

    Product
    Amazon Go Vegan Hummus Veggies - Hummus Dip with Veggies, Net weight: 6.2 ounces. UPC: 8 42379 12606 2.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0598-2020·2019-12-11

    Allergan Recalls XEN Gel Stent Due to Residual Polishing Compounds

    Allergan is recalling XEN Gel Stent implants because residual polishing compounds on the injector needle may transfer to the patient's eye, causing irritation or inflammation.

    Product
    XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V877000·2019-12-11

    Toyota Recalls Corolla and C-HR Vehicles for Rear Seat Belt Defect

    Toyota is recalling 2019-2020 Corolla, Corolla Hybrid, and C-HR vehicles because the rear seat belt locking mechanism may not function correctly, increasing injury risk in crashes.

    Product
    TOYOTA — TOYOTA COROLLA HYBRID, COROLLA, C-HR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0206-2020·2019-12-11

    Amazon Recalls Tzatziki Dip with Veggies Due to Listeria Risk

    Amazon is recalling refrigerated Tzatziki Dip with Veggies due to potential Listeria monocytogenes contamination. The product was distributed in Washington.

    Product
    Amazon Go Tzatziki Dip with Veggies, refrigerated. Net weight: 6.2 ounces. UPC: 8 42379 12607 9.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0594-2020·2019-12-11

    Zimmer Biomet Recalls 13MM Intramedullary Bone Saw Cam Assemblies

    Zimmer Biomet is recalling 26 units of 13MM Intramedullary Bone Saw Cam Assemblies due to possible commingling with 14MM units.

    Product
    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0204-2020·2019-12-11

    GH Imports Recalls Minced Onion Due to Metal Filament

    GH Imports, Inc. is recalling 1,020 cartons of minced onion from China due to a reported metal filament. The product was distributed only in Puerto Rico.

    Product
    Onion Minced: 16-40 Mesh, Net Weight: 24/kg/52.91lbs, Manufacturing Date: May, 2019, Country of Origin: China, Manufactured for GH Imports Inc.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0553-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Infusion Bags Due to Glass Particulates

    QuVa Pharma is recalling fentanyl infusion bags because they may contain glass particulates. The affected product is distributed nationwide.

    Product
    fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·19V876000·2019-12-11

    Toyota Recalls 2019 Prius Vehicles Due to Electrical Short Circuit Risk

    Toyota is recalling 2019 Prius vehicles because an electrical short circuit in the combination meter could cause the speedometer, odometer, and fuel gauge to go blank, increasing crash risk.

    Product
    TOYOTA — TOYOTA PRIUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0208-2020·2019-12-11

    Fortune Fish & Gourmet Recalls Fresh Atlantic Salmon for Listeria Risk

    Fortune Fish & Gourmet is recalling fresh Atlantic salmon that may be contaminated with Listeria monocytogenes. The product was sold in retail and foodservice locations in eight states.

    Product
    Fortune Fish & Gourmet fresh Atlantic salmon, whole, filleted, and filleted without belly sold by weight in cardboard box with ice
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-0555-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Infusions Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl 10 mcg/mL infusion bags nationwide due to the potential presence of glass particulate matter.

    Product
    fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2020·2019-12-11

    Stryker Recalls Disposable Tourniquet Cuffs Due to Air Leak Risk

    Stryker is recalling 16,380 disposable tourniquet cuffs because they may leak air, causing a loss of vascular occlusion during surgery.

    Product
    Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0207-2020·2019-12-11

    Amazon Meal Kit Veggie Quinoa Bowl Recalled for Listeria Contamination

    Amazon is recalling 23 kits of Veggie Quinoa Bowl with Spiced Garbanzo Beans due to potential Listeria monocytogenes contamination.

    Product
    Amazon Meal Kit Veggie Quinoa Bowl with Spiced Garbanzo Beans, Net weight: 3 pounds 2 ounces. UPC: 842379110078. Amazon Meal Kit Veggie Quinoa Bowl with Spiced Garbanzo Beans contains a recipe card that includes cooking instructions.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0608-2020·2019-12-11

    Philips HeartStart XL+ Defibrillator Recall for Power-On Failure

    Philips is recalling 24,738 HeartStart XL+ Defibrillator/Monitor units because they may fail to turn on or restart, rendering them unable to return to a ready-for-use state.

    Product
    HeartStart XL+ Defibrillator/Monitor, Model 861290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V875000·2019-12-11

    Porsche Recalls 15,501 Vehicles for Child Seat Manual Deficiency

    Porsche is recalling 15,501 vehicles because the owner's manual lacks specific instructions for installing child restraint systems, which may increase injury risk in a crash.

    Product
    PORSCHE — PORSCHE CAYMAN, 911 GT3, 911 GT3 RS, 911 R
    Category
    Vehicle
    Distribution
    Distributed nationwide