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.

28351–28375 of 50488

  • HighFDA (Food)·F-1617-2018·2018-07-18

    Citron Tea Recalled for Undeclared Allergens in Citron Powder

    Hee Chang Dairy & Food Co. is recalling Citron Tea packets because the citron powder contains undeclared corn syrup and lactose.

    Product
    Citron Tea; 35.3 oz. (1 kg) packet Ingredients: White Sugar, Dried Citron Powder, Citric Acid, carboxymethylcellulose, Sodium citrate; Silicon dioxide, Citron Flavor. Citron Powder contains corn syrup 58% and Lactose 20% Imported and Distributed by: Coffee Tree USA…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1611-2018·2018-07-18

    FDA Recalls Frozen Tilapia Fillets Due to Listeria Monocytogenes Contamination

    R F A Inc. is recalling frozen natural tilapia fillets packed for Osamu Corporation due to potential Listeria monocytogenes contamination.

    Product
    Frozen Natural Tilapia + Belly V-Pack, Farm Raised Tilapia, Product of Costa Rica, Packed for Osamu Corporation Carson, California 90810
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2411-2018·2018-07-18

    Fort Defiance P2131 Steam Sterilizer Recalled for Plumbing Deposits

    Fort Defiance Industries is recalling 199 P2131 Automated Field Steam Sterilizers because stagnant water and metal interactions can create deposits that interfere with the rear sight gauge or water liquid level switch.

    Product
    FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1616-2018·2018-07-18

    Black Bean Job's Tears Tea Recalled for Undeclared Allergens

    Hee Chang Dairy & Food Co., LTD is recalling Black Bean Job's Tears Tea because FDA inspection found undeclared allergens in the product.

    Product
    Black Bean Job's Tears Tea, 35.3 oz. (KG) package Ingredients: Non Dairy Creamer (corn syrup, Palm oil, Lactose, Whey Powder, Dipotassium Phosphate, Silicon dioxide, Refined Salt, Milk flavor), citron Syrup, Rice, Job's Tears Corn, Black Bean Powder, guar gum. The…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2422-2018·2018-07-18

    Cayenne Medical Recalls AperFix AM Femoral Implants Due to Breakage Risk

    Cayenne Medical Inc. is recalling 976 units of AperFix AM Femoral Implants because they may break inside the femoral socket during orthopedic use.

    Product
    AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2416-2018·2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 103 EnTrust Dual Chamber ICDs because they may lose high voltage and anti-tachycardia pacing therapy near end-of-life without prior warning.

    Product
    Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2391-2018·2018-07-18

    Ekla Recalls NOVAPLUS Pregnancy Test Kits Due to Incorrect Results

    Ekla Corporation is recalling 295 NOVAPLUS Pregnancy Cassette Devices because they may provide incorrect hCG results. The affected kits were distributed in California, Illinois, Minnesota, and Rhode Island.

    Product
    NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2414-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk

    Medtronic is recalling 1,604 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.

    Product
    Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2427-2018·2018-07-18

    FDA Recalls LigaSure Exact Dissector Nano Coated Due to Sterile Breach

    FDA is recalling 936 units of LigaSure Exact Dissector Nano Coated instruments because sterile pouches were found with punctures.

    Product
    LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V473000·2018-07-17

    BMW Recalls 2018 M5 Vehicles Due to Fuel Level Sensor Defect

    BMW is recalling 2018 M5 vehicles because a fuel level sensor may stick to a fuel line, causing inaccurate fuel gauge readings that could lead to stalling and increased crash risk.

    Product
    BMW — BMW M5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V470000·2018-07-16

    Ford Recalls 2018 F53 Chassis Due to Wheel Stud Defect

    Ford is recalling 2018 F53 stripped chassis vehicles because improperly heat-treated front wheel studs may break, increasing crash risk.

    Product
    FORD — FORD F53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V467000·2018-07-13

    Volkswagen Recalls 2018 Tiguan Vehicles Due to Sunroof Fire Risk

    Volkswagen is recalling 2018 Tiguan vehicles because the panoramic sunroof LED module may short circuit, increasing the risk of a fire.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V466000·2018-07-12

    Multiquip Recalls 2018 Trailers Due to Center-Mounted Jack Collapse Risk

    Multiquip is recalling 2018 TRLR45H and TRLR70USH trailers because the center-mounted jack may collapse under excessive load, increasing the risk of injury.

    Product
    MULTIQUIP — MULTIQUIP TRLR45H, TRLR70USH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0901-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2372-2018·2018-07-11

    Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses because black residue was found in the polyethylene packaging. The firm states the residue is biocompatible, but it may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20; 00-7713-020-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1609-2018·2018-07-11

    FUNKTIONAL FOODS Spirulina Powder Recalled for Undeclared Sulfites

    The TJX Companies is recalling FUNKTIONAL FOODS Spirulina Powder because it contains undeclared sulfites. Consumers should stop using the product.

    Product
    FUNKTIONAL FOODS brand SPIRULINA POWDER, NET WEIGHT 3.5 oz (100 g) with UPC Code: 060427570192
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2342-2018·2018-07-11

    Beaver Visitec Safety Sideport Knife Blades May Detach During Surgery

    Beaver Visitec is recalling Safety Sideport Knives because blades may fall out of handles due to non-cured epoxy. The defect poses a risk during ophthalmic surgery.

    Product
    Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V464000·2018-07-11

    Volkswagen Recalls 2015-2018 Golf Models for Ignition Key Removal Defect

    Volkswagen is recalling 2015-2018 Golf and Golf Sportwagen vehicles because silicate buildup may allow the key to be removed while the car is not in Park, increasing rollaway risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF, GOLF SPORTWAGEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2366-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 11; 00-7713-011-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2295-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation Complaints

    Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to higher-than-expected complaints of femoral head/hip stem disassociation.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1605-2018·2018-07-11

    SNI Recalls Nitric Blast Pink Lemonade for DMAA Ingredient

    SNI, LLC is recalling Nitric Blast Pink Lemonade products containing geranium extract (DMAA) as a dietary ingredient.

    Product
    SNI Nitric Blast Pink Lemonade 276gr (UPC ending in 5598)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2361-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but may cause surgical delays or wear-related intervention.

    Product
    Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
    Category
    Medical Device
    Distribution
    0 states