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.

35476–35500 of 50504

  • HighNHTSA·16E058000·2016-06-20

    Speedtech Recalls Nitrous Solenoid Valves Due to Welding Defect

    Speedtech LLC is recalling Nitrous Solenoid Valves used in drag racing nitrous oxide systems because improper welding may cause the valve to separate and eject the piston under pressure.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V446000·2016-06-17

    Indian Recalls 2014-2016 Motorcycles Due to Fire Risk

    Indian Motorcycle is recalling 2014-2016 models because engine misfires can raise exhaust temperatures, increasing the risk of fire.

    Product
    INDIAN — INDIAN CHIEF CLASSIC, CHIEFTAIN, ROADMASTER, VINTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V442000·2016-06-16

    Mercedes-Benz Recalls 2015-2016 Models for Seatbelt Anchor Bolt Defect

    Mercedes-Benz is recalling certain 2015-2016 models because the right rear seatbelt anchor bolt may be incorrectly installed, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE450, AMG ML63, ML250, ML350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V443000·2016-06-16

    E-One Recalls Cyclone II and Typhoon Vehicles for Electrical Fire Risk

    E-One is recalling 2014-2016 Cyclone II and Typhoon vehicles because a power control module defect may cause a short circuit, leading to electrical damage or fire.

    Product
    E-ONE — E-ONE CYCLONE II, TYPHOON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V444000·2016-06-16

    Land Rover Recalls 2016 LR4 Vehicles Due to Frontal Air Bag Defect

    Jaguar Land Rover is recalling 2016 LR4 vehicles because the driver-side frontal air bag may not inflate properly, increasing injury risk in a crash.

    Product
    LAND ROVER — LAND ROVER LR4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2016·2016-06-15

    Materialise Recalls Patient-Specific Knee Surgical Guide Set Due to Fit Error

    Materialise USA LLC is recalling a patient-specific knee surgical guide set because the femur guide does not match the patient, preventing proper use during surgery.

    Product
    Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1438-2016·2016-06-15

    Frontier Co-op Hojicha Tea Recalled Due to Potential Salmonella Contamination

    Frontier Natural Products CO-OP is recalling specific lots of Hojicha Tea due to potential Salmonella contamination. Consumers should stop using the affected products.

    Product
    16 oz. foil packages of Frontier Co-op Hojicha Tea Certified Organic Camellia sinensus, Norway, IA 52318
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0996-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Methyl B12 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Methyl B12 vials because FDA inspections found violations that may affect sterility.

    Product
    M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0982-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Estradiol Valerate Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Estradiol Valerate 10mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1922-2016·2016-06-15

    Baxter Recalls Actifuse Bone Void Fillers Due to Endotoxin Concerns

    Baxter Healthcare is voluntarily recalling Actifuse ABX and MIS System bone void fillers because they may contain endotoxin levels above specification criteria.

    Product
    Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1436-2016·2016-06-15

    Honest Kids Super Fruit Punch Recalled for Missing Apple Juice Labeling

    The Coca-Cola Company is recalling Honest Kids Super Fruit Punch because the label fails to list apple juice, a common allergen, as an ingredient.

    Product
    Honest Kids-Super Fruit Punch, Organic Juice Drink, 59 fluid oz. bottle, 006 57622 41273 7, Honest Tea, Inc., 4827 Bethesda Ave., Bethesda, MD 20814.
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-1915-2016·2016-06-15

    GE Revolution CT Patient Table Recalled for Unintended Motion Risk

    GE Healthcare is recalling Revolution CT Patient Tables because the cradle can descend on its own, posing a crushing risk to large patients.

    Product
    GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2016·2016-06-15

    Philips Brilliance iCT CT System Software Defect Recall

    Philips Healthcare is recalling Brilliance iCT Computed Tomography X-Ray Systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1832-2016·2016-06-15

    Hospira Recalls 1,490 Plum 360 Infusion Pumps Due to Calibration Error

    Hospira is recalling 1,490 Plum 360 infusion pumps because a calibration error may cause false proximal occlusion alarms.

    Product
    The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1418-2016·2016-06-15

    Werner Brand Sweet Hot Crunch Mix Recalled for Undeclared Milk Allergen

    Werner Gourmet Meat Snacks is recalling Sweet Hot Crunch Mix because the label declares butter but fails to declare milk, a major allergen.

    Product
    Werner Brand Sweet Hot Crunch Mix, net wt. 2 oz, UPC 7 09972 80120 1. Werner Brand Sweet Hot Crunch Mix, net wt. 6 oz, UPC 7 09972 80100 3. The ingredients statement declared: "***BUTTER TOFFEE PEANUTS (PEANUTS, SUGAR, BUTTER, SALT)***". The label contains…
    Category
    Food
    Distribution
    19 states
  • HighFDA (Drugs)·D-1023-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Vitamin B Complex Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Vitamin B Complex # 1 vials because FDA inspections found GMP violations that may affect sterility.

    Product
    VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1435-2016·2016-06-15

    7-Eleven Fresh To Go Sugar Cookies Recalled for Undeclared Peanuts

    Dough Masters is recalling 7-Eleven Fresh To Go Sugar Cookies with M&M Chocolate Candy because they may contain undeclared peanuts.

    Product
    7-ELEVEN FRESH TO GO SUGAR COOKIE WITH M&M CHOCOLATE CANDY, 2 pieces, NET WT. 4 OZ. The affected cookies are packed in a clear, plastic film, two cookies per package.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1912-2016·2016-06-15

    DePuy Synthes Flexible Shaft Reamers Recalled for Cytotoxicity Failure

    Synthes (USA) Products LLC is recalling 244 DePuy Synthes 8.0 mm Flexible Shaft Reamers because they failed biological safety evaluations for cytotoxicity.

    Product
    DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1011-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Testosterone Cypionate 100mg/mL vials because FDA inspections found GMP violations that may affect sterility.

    Product
    TESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1917-2016·2016-06-15

    Zimmer Biomet Recalls Persona Trabecular Metal Tibial Plate Instruments

    Zimmer Biomet is recalling specific Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets due to incidents of radiolucent lines and loosening in implants.

    Product
    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1925-2016·2016-06-15

    Berchtold Recalls Surgical Table Cushions Due to Potential Staple Contamination

    Berchtold Corp. is recalling 227 HybriGel surgical table cushions because they may contain staples that could appear on patient x-rays.

    Product
    Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1423-2016·2016-06-15

    Karlsburger Mesquite Seasoning Mix Recalled for Undeclared Soy Allergen

    Karlsburger Foods is recalling 2 lb containers of Mesquite Seasoning Mix because they contain undeclared soy, a major food allergen.

    Product
    Karlsburger, Mesquite Seasoning Mix & Marinade, Item 46402, Net WT 2 lbs in plastic shaker jars.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1718-2016·2016-06-15

    Philips Healthcare Ingenuity Core128 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Ingenuity Core128 CT systems in the US due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states