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.

37476–37500 of 50506

  • HighNHTSA·15V656000·2015-10-14

    Toyota Recalls 2016 Tacoma Trucks Due to Knee Air Bag Bolt Issue

    Toyota is recalling 2016 Tacoma trucks because incorrect bolts were used to install the driver's knee air bag module, which may loosen over time.

    Product
    TOYOTA — TOYOTA TACOMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V655000·2015-10-14

    Mercedes-Benz Recalls 2014-2015 B-Class Electric Drive Vehicles for Software Defect

    Mercedes-Benz is recalling 2,618 model year 2014-2015 B-Class Electric Drive vehicles because a communication error may cause the electric powertrain to shut down, temporarily immobilizing the vehicle.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ B-CLASS ELECTRIC, B 250E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Hip Shoulder Surgical Kits

    Resource Optimization & Innovation LLC is recalling 92 sterile hip shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0051-2016·2015-10-14

    FDA Recalls 48 Neuro Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 48 sterile neuro surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0079-2016·2015-10-14

    Resource Optimization & Innovation LLC Recalls Sterile C-Section Surgical Kits

    Resource Optimization & Innovation LLC is recalling 72 sterile C-section surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0005-2016·2015-10-14

    Caribou Coffee Recalls Biscotti for Missing Soy Ingredient Labeling

    Caribou Coffee Company Inc. is recalling two types of biscotti because soy lecithin was missing from the ingredient list.

    Product
    Caribou Chocolate Chip Toffee Pecan Biscotti, Net Wt. 1.4 oz. (40g) in clear cello flow wrap bag.
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0107-2016·2015-10-14

    Siemens SOMATOM Force CT Systems Recalled for Software and Firmware Bugs

    Siemens Medical Solutions USA is recalling 21 SOMATOM Force computed tomography systems due to software and firmware bugs.

    Product
    SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2016·2015-10-14

    Resource Optimization & Innovation Recalls 164 Arthroscopy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 164 arthroscopy surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0084-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Total Knee Surgical Kits

    Resource Optimization & Innovation LLC is recalling 40 sterile total knee surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0055-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Abdominal Surgical Kits

    Resource Optimization & Innovation LLC is recalling 712 sterile abdominal surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0038-2016·2015-10-14

    FDA Recalls Robotic Hysterectomy Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 324 robotic hysterectomy surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0085-2016·2015-10-14

    FDA Recalls 658 Sterile Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 658 sterile surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0044-2016·2015-10-14

    FDA Recalls 146 Sterile C-Section Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 146 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0114-2016·2015-10-14

    Stryker Recalls Disposable Paper Filters for Sterilization Containers

    Stryker is recalling disposable paper filters for sterilization containers because inhomogeneous paper may compromise the sterile barrier during shelf-life.

    Product
    Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0086-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile C Section Surgical Kits

    Resource Optimization & Innovation LLC is recalling 388 sterile C Section surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0089-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits

    Resource Optimization & Innovation LLC is recalling 1,400 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0050-2016·2015-10-14

    Resource Optimization & Innovation Recalls 516 Sterile Lap Chole Surgical Kits

    Resource Optimization & Innovation LLC is recalling 516 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0031-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits

    Resource Optimization & Innovation LLC is recalling 600 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0063-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits

    Resource Optimization & Innovation LLC is recalling 416 sterile C-section surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighNHTSA·15V657000·2015-10-14

    Mercedes-Benz Recalls 2015 S-Class Models Due to Seat Belt Installation Error

    Mercedes-Benz is recalling 2,580 model year 2015 S550 4Matic, AMG S63, and AMG S65 vehicles because front seat belts may be installed on the wrong side, affecting crash protection.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG S63, AMG S65, S550 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2016·2015-10-14

    Resource Optimization & Innovation LLC Recalls Sterile Extremity Surgical Kits

    Resource Optimization & Innovation LLC is recalling 672 sterile extremity surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0062-2016·2015-10-14

    Resource Optimization & Innovation LLC Recalls Pediatric Cardiac Catheterization Surgical Kits

    Resource Optimization & Innovation LLC is recalling 24 pediatric cardiac catheterization surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0087-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 68 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states