The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

21676–21700 of 32121

  • SevereFDA (Devices)·Z-0059-2016·2015-10-14

    FDA Recalls 726 Sterile Laparoscopic Cholecystectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 726 sterile surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800551, Sterile, GS0640 - Lap Chole - 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
  • SevereFDA (Devices)·Z-0111-2016·2015-10-14

    DePuy Orthopaedics Recalls Specialist 2 Intramedullary Rod Instruments Due to Fracture Complaints

    DePuy Orthopaedics is voluntarily recalling select lots of the Specialist 2 Intramedullary Rod 400mm Instrument because the rod has fractured, leaving portions inside patients.

    Product
    Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with…
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Devices)·Z-0082-2016·2015-10-14

    FDA Recalls Pacemaker Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 40 pacemaker surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 880328, Sterile, HT0759 - Pacemaker 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
  • SevereFDA (Devices)·Z-0033-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits

    Resource Optimization & Innovation LLC is recalling 199 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800410, Sterile, CV0479 - Open Heart 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
  • SevereFDA (Devices)·Z-0074-2016·2015-10-14

    FDA Recalls Robotic Laparoscopic Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 144 robotic laparoscopic surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - 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
  • SevereNHTSA·15V652000·2015-10-14

    Mercedes-Benz Recalls S63 AMG Sedans and Coupes for Engine Stall Risk

    Mercedes-Benz is recalling 2014-2016 S63 AMG vehicles because a software error may cause the engine to stall and fail to restart, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG S63 4MATIC, AMG S63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2016·2015-10-14

    FDA Recalls 64 Sterile Peripheral Vascular Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 64 sterile surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - 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
  • SevereFDA (Drugs)·D-0007-2016·2015-10-14

    Merck Recalls Vytorin Tablets Due to Foreign Tablet Presence

    Merck Sharp & Dohme is recalling specific bottles of Vytorin 10 mg/20 mg tablets because they contain 10 mg/40 mg tablets. The recall affects distribution in Kentucky, Mississippi, and Ohio.

    Product
    Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0092-2016·2015-10-14

    FDA Recalls 214 Sterile Neuro Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 214 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800411002, Sterile, NU0480B - 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…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0006-2016·2015-10-14

    Sermorelin Injection Recalled Due to Sterility Assurance Concerns

    DCA Pharmacy is recalling 129 vials of Sermorelin 6mg/6mL Lyophilized Powder because an FDA inspection found it was not compounded in an appropriate area, potentially compromising sterility.

    Product
    Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0078-2016·2015-10-14

    FDA Recalls 24 Sterile Breast Surgical Kits Due to Sterility Compromise

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

    Product
    regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0052-2016·2015-10-14

    Resource Optimization & Innovation Recalls Vaginal Hysterectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 36 vaginal hysterectomy surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - 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
  • SevereFDA (Devices)·Z-0070-2016·2015-10-14

    FDA Recalls Robotic Hysterectomy Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 144 robotic hysterectomy surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - 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
  • SevereFDA (Devices)·Z-0068-2016·2015-10-14

    Resource Optimization & Innovation LLC Recalls Pediatric Heart Surgical Kits

    Resource Optimization & Innovation LLC is recalling 24 pediatric heart surgical kits due to potential sterility compromise from defective equipment gloves.

    Product
    regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - 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
  • SevereFDA (Devices)·Z-0112-2016·2015-10-14

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling Monaco Radiation Treatment Planning System software version 5.10.00 because it may calculate incorrect dose and MU values under specific conditions.

    Product
    Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • SevereNHTSA·15V642000·2015-10-13

    Newmar Recalls 2016 Motorhomes Due to Parking Brake Calibration Defect

    Newmar is recalling 86 model year 2016 Bay Star and Canyon Star motorhomes because the parking brake may fail to hold the vehicle or disengage properly.

    Product
    NEWMAR — NEWMAR BAY STAR, BAY STAR SPORT, CANYON STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V649000·2015-10-13

    Great Dane Recalls 2016 Trailers Due to Axle Nut Retaining Clip Defect

    Great Dane is recalling 2016 Dry Freight and Converter Dolly trailers because axle nut retaining clips may be missing or improperly seated, risking wheel loss and loss of vehicle control.

    Product
    GREAT DANE — GREAT DANE CONVERTER DOLLY, DRY FREIGHT SEMI-TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V651000·2015-10-13

    Volvo Recalls 2009-2015 VN Trucks for Steering Loss Risk

    Volvo is recalling 2009-2015 VN trucks because corrosion of ball joints may cause loss of steering. Owners should contact dealers for free inspection and replacement.

    Product
    VOLVO — VOLVO VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V646000·2015-10-13

    E-One Emergency Vehicles Recalled for Disconnected Air Bag Harness

    E-One is recalling 2014-2015 Cyclone II, Typhoon, and Quest emergency vehicles because the front air bag harness may be disconnected, preventing deployment in a crash.

    Product
    E-ONE — E-ONE CYCLONE II, TYPHOON, QUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V639000·2015-10-09

    PACCAR Recalls 2016 Peterbilt and Kenworth Trucks for Transmission Defect

    PACCAR is recalling 2016 Peterbilt and Kenworth trucks because the transmission may lock or cause unexpected backward movement, increasing crash risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 367, 384, 579, 567
    Category
    Vehicle
    Distribution
    Distributed nationwide