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.

20951–20975 of 32121

  • SevereFDA (Food)·F-0453-2016·2016-01-06

    Helados La Tapatia Cookies 'n' Cream Ice Cream Recalled for Allergens

    Helados La Tapatia is recalling Cookies 'n' Cream ice cream bars because they contain undeclared soy and wheat allergens.

    Product
    Helados La Tapatia ; Cookies 'n' Cream Biscuits au Chocolat; Net Wt. 4 oz, (113g) UPC 6 34242 60007 2; INGREDIENTS FOR ICE FRUIT BARS: ICE CREAM MIX (CREAM, MILK, FRESH CONDENSED SKIM MILK, SUCROSE, CORN SYRUP. DESSERT SOLIDS (WHEY, REDUCED LACTOSE, WHEY AND NON FAT…
    Category
    Food
    Distribution
    4 states
  • SevereUSDA FSIS·004-2016·2016-01-06

    Neto's Sausage Recalls Meat and Poultry Products Labeled Without Inspection

    Neto's Sausage Co. is recalling approximately 7,687 pounds of beef, pork, and chicken products that were labeled with the federal mark of inspection without FSIS oversight.

    Product
    Silva Sausage Co. — Neto's Sausage Co., Inc. Recalls Meat and Poultry Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0556-2016·2016-01-06

    Walgreens Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 43 bags of 0.9% Sodium Chloride injection in Texas due to a lack of assurance of sterility.

    Product
    0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·16V002000·2016-01-05

    HME Recalls One 2015 SFO Fire Service Chassis for Axle Defect

    HME is recalling one 2015 SFO fire service chassis because improperly tightened axle nuts could cause the driveshaft to disconnect, increasing crash risk.

    Product
    HME — HME SFO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·003-2016·2016-01-05

    Wegmans Recalls Chicken Products Produced Without Federal Inspection

    Wegmans is recalling approximately 1,125 pounds of chicken products produced without federal inspection. The products were shipped to six states.

    Product
    Wegmans Food Markets — Wegmans Food Markets Recalls Chicken Products Produced Without Benefit Of Inspection
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0448-2016·2015-12-30

    Aesculap Flexible Orthopedic Instrument Tray Set Recalled for Breakage Risk

    Aesculap, Inc. is recalling flexible orthopedic instrument tray sets because the shafts may break during surgery, potentially leaving fragments in patients.

    Product
    Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0392-2016·2015-12-30

    Boston Scientific Recalls Chariot Guiding Sheaths Due to Shaft Separation

    Boston Scientific is voluntarily recalling Chariot Guiding Sheaths after receiving complaints about shaft separation, which could lead to embolism of device fragments.

    Product
    Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0441-2016·2015-12-30

    Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC 256 Antimicrobial Susceptibility Tests

    Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.

    Product
    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0439-2016·2015-12-30

    Biomerieux Recalls Etest Piperacillin/Tazobactam Tests Due to False Results

    Biomerieux is recalling Etest Piperacillin/Tazobactam tests because they may report false susceptible results for bacteria.

    Product
    Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0543-2016·2015-12-30

    Philips Recalls Cardinal Health Tiny Toes Infant Heel Warmers

    Philips Electronics North America is recalling Cardinal Health Tiny Toes infant heel warmers because they may cause first and second degree burns.

    Product
    Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0435-2016·2015-12-30

    Salted Smoked Split Herring Recalled for Being Uneviscerated

    P East Trading Corporation is recalling salted smoked split herring in bulk wooden boxes because the product was found to be uneviscerated.

    Product
    Salted Smoked Split Herring in bulk wooden boxes, Net Wt. 18 lbs., Product of Canada --- No label provided for bulk product.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0436-2016·2015-12-30

    Draeger Recalls Optional PS500 Power Supply Units for Ventilators

    Draeger Medical is recalling 2,422 optional PS500 power supply units for Evita V500 and Babylog VN500 ventilators due to unexpectedly short battery run times.

    Product
    Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0483-2016·2015-12-30

    Cardica Recalls MicroCutter Xchange 30 Blue Curved Tip Cartridges

    Cardica, Inc. is recalling MicroCutter Xchange 30 Blue Curved Tip Cartridges because incomplete staple firing may result in incomplete tissue transection or anastomosis during surgery.

    Product
    MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which…
    Category
    Medical Device
    Distribution
    16 states
  • SevereNHTSA·15V887000·2015-12-30

    BMW Recalls Two 2016 Models for Steering Gearbox Defect

    BMW is recalling two 2016 vehicles (one MINI Cooper Convertible, one BMW X1) because incorrect steering gearbox parts may cause loss of vehicle control.

    Product
    BMW — BMW, MINI X1, COOPER CONVERTIBLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0424-2016·2015-12-30

    Aesculap Flexible Drill Recalled Due to Potential Shaft Breakage During Surgery

    Aesculap, Inc. is recalling 13 Flexible Drill instruments (SJ723R) because the flexible shaft may break during orthopedic spinal surgery, posing a risk of surgical delay or retained fragments.

    Product
    Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0440-2016·2015-12-30

    Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC Antimicrobial Susceptibility Tests

    Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC antimicrobial susceptibility tests due to the potential for reporting erroneous results, specifically false susceptible results for Piperacillin/Tazobactam.

    Product
    Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0482-2016·2015-12-30

    Cardica Recalls MicroCutter Xchange 30 Blue Cartridges Due to Firing Defect

    Cardica, Inc. is recalling MicroCutter Xchange 30 Blue Cartridges because they may fail to fire staples completely, potentially causing incomplete tissue transection or anastomosis during surgery.

    Product
    MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient…
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Food)·F-0285-2016·2015-12-30

    United Trading Center Recalls Golden Raisins for Undeclared Sulfites

    United Trading Center Inc. is recalling 16-ounce packages of Basma golden raisins because they contain undeclared sulfites. The product was distributed in New York and Pennsylvania.

    Product
    Basma 3 Chris Court Dayton, New Jersey 08810 Tel.:7323559600 Fax: 7323559644 16 oz package This golden raisin product is labeled in a foreign language.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0422-2016·2015-12-30

    Aesculap Flexible Screw Driver Recalled Due to Potential Shaft Breakage

    Aesculap, Inc. is recalling 37 Flexible Screw Driver SJ706R units because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.

    Product
    Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V883000·2015-12-29

    Micro Bird Recalls 2014-2016 School Buses for Loose Wheel Bolts

    Micro Bird is recalling 464 school buses because a camber caster kit bolt may be insufficiently torqued, posing a risk of vehicle misalignment and loss of control.

    Product
    MICRO BIRD — MICRO BIRD MB II SCHOOL BUS, G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V884000·2015-12-29

    Micro Bird Recalls Transit Buses Due to Loose Wheel Bolt

    Micro Bird is recalling 2014-2016 G5 and MB II transit buses because a wheel bolt may be insufficiently torqued, posing a risk of vehicle misalignment and loss of control.

    Product
    MICRO BIRD — MICRO BIRD MB II TRANSIT BUS, G5 TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V881000·2015-12-28

    Ferrari Recalls 2016 488 GTB Vehicles for Fuel Line Fire Risk

    Ferrari is recalling 119 model year 2016 488 GTB vehicles because a fuel line connection may leak vapor, increasing fire risk.

    Product
    FERRARI — FERRARI 488 GTB
    Category
    Vehicle
    Distribution
    Distributed nationwide