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.

18751–18775 of 32108

  • SevereFDA (Devices)·Z-0378-2017·2016-11-16

    Stryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure

    Stryker Howmedica Osteonics is recalling specific lots of LFIT Anatomic V40 Femoral Heads because of reported taper lock failures that caused harm.

    Product
    LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0126-2017·2016-11-16

    FDA Recalls Wells Pharmacy Testosterone and Anastrozole Pellets

    Wells Pharmacy Network is recalling compounded Testosterone 200 mg/Anastrozole 9 mg Pellets because they are superpotent or subpotent.

    Product
    Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0309-2017·2016-11-16

    Ev3 Neurovascular Recalls Marathon and UltraFlow Micro Catheters

    Micro Therapeutics Inc. is recalling Marathon and UltraFlow HPC Flow Directed Micro Catheters because PTFE coating may delaminate and enter the bloodstream.

    Product
    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V826000·2016-11-15

    Newmar Recalls 2016-2017 Dutch Star and Ventana Motorhomes for Fire Risk

    Newmar is recalling 370 model year 2016-2017 Dutch Star and Ventana motorhomes because a power steering hose may rub against the starter motor, causing electrical arcing and a fire risk.

    Product
    NEWMAR — NEWMAR DUTCH STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V822000·2016-11-14

    Keystone Recalls 2017 Cougar Fifth Wheel Trailers for Propane Leak Risk

    Keystone RV Company is recalling specific 2017 Cougar fifth wheel trailers because a propane manifold may contact floor fasteners, creating a potential leak and fire hazard.

    Product
    KEYSTONE — KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V814000·2016-11-10

    Chrysler Recalls 2016 Dodge Durango and Jeep Grand Cherokee for Fuel Leak Risk

    Chrysler is recalling 2016 Dodge Durango and Jeep Grand Cherokee vehicles due to a potential fuel rail crossover tube defect that may cause a fuel leak and increase fire risk.

    Product
    DODGE — DODGE, JEEP DURANGO, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V815000·2016-11-10

    Kia Recalls 2008-2009 Sportage Vehicles Due to Fire Risk

    Kia is recalling 2008-2009 Sportage vehicles because a wire harness cover may allow water to enter, causing corrosion and an increased risk of engine compartment fire.

    Product
    KIA — KIA SPORTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0326-2017·2016-11-09

    Hill-Rom Recalls Ceiling Brackets Due to Potential Fall Hazard

    Hill-Rom is recalling 188 ceiling brackets with a larger center hole that could cause the system to fall if the safe working load is exceeded.

    Product
    Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0125-2017·2016-11-09

    PharMEDium Recalls Succinylcholine Chloride Vials Due to Sterility Concerns

    PharMEDium Services is recalling specific vials of Succinylcholine Chloride because a portion of the batch was compounded outside of validated process media, raising sterility concerns.

    Product
    Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0325-2017·2016-11-09

    FDA Recalls Encore Medical Empowr PS Knee System Box Cut Guides

    Encore Medical is recalling 436 units of the Empowr PS Knee System Box Cut Guide because the design can cause femoral chipping during surgery.

    Product
    Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0357-2017·2016-11-09

    Unomedical AC TenderLink Insulin Infusion Tubing Recalled for Detachment Risk

    Unomedical As is recalling AC TenderLink insulin infusion tubing sets due to a risk of tubing detachment. The voluntary recall affects 653,280 units distributed in the US and internationally.

    Product
    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0349-2017·2016-11-09

    Battle Creek Thermophore Deep-Heat Therapy Devices Recalled for Fire Risk

    Battle Creek Equipment Co. is recalling Thermophore Classic and Plus deep-heat therapy devices because the power cord can spark, causing smoke, fire, and burns.

    Product
    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-0373-2017·2016-11-09

    7-Eleven Sugar Cookie with M&M Chocolate Candy Recalled for Undeclared Peanuts

    Glenn Wayne Wholesale Bakery Inc. is recalling 7-Eleven Fresh To Go Sugar Cookies with M&M Chocolate Candy due to undeclared peanuts.

    Product
    7-ELEVEN FRESH TO GO SUGAR COOKIE WITH M&M CHOCOLATE CANDY, NET WT. 4 OZ., UPC 052548558765; Manhattan UPC: 052548570644
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0371-2017·2016-11-09

    7-Eleven Chocolate Chunk Cookie Recalled for Undeclared Peanuts

    Glenn Wayne Wholesale Bakery is recalling 7-Eleven Fresh To Go Chocolate Chunk Cookies in New York State because they may contain undeclared peanuts.

    Product
    7-ELEVEN FRESH TO GO CHOCOLATE CHUNK COOKIE, NET WT. 4 OZ., UPC 052548558741; Manhattan UPC: 052548570668 --
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·102-2016 EXP·2016-11-09

    Flavor Trade Recalls Beef Jerky Produced Without Federal Inspection

    Flavor Trade, LLC. is recalling 741 pounds of beef jerky produced without federal inspection and shipped to Kansas and Missouri.

    Product
    Flavor Trade, LLC. Recalls Beef Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0374-2017·2016-11-09

    Whole Foods Asparagus Pea Salad Recalled for Undeclared Eggs

    Whole Foods Market is recalling Asparagus Pea & Ricotta Salad because it contains undeclared eggs. The product was sold in five northeastern states.

    Product
    Whole Foods Asparagus Pea & Ricotta Salad, 10 Ounces
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0372-2017·2016-11-09

    7-Eleven Oatmeal Raisin Cookies Recalled for Undeclared Peanuts

    Glenn Wayne Wholesale Bakery is recalling 7-Eleven Fresh To Go Oatmeal Raisin Cookies sold in New York State because they may contain undeclared peanuts.

    Product
    7-ELEVEN FRESH TO GO OATMEAL RAISIN COOKIE, NET WT. 4 OZ., UPC 052548558758; Manhattan UPC: 052548570651
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0337-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-0375-2017·2016-11-09

    Osage Gardens Recalls Organic Micro Greens Due to Salmonella Test

    Osage Gardens is voluntarily recalling 222 units of Organic 2oz Micro Greens after a positive test for Salmonella. The product was distributed in Colorado and Kansas.

    Product
    Organic 2oz Micro Greens. Clear Plastic Clamshell. Keep Refrigerated
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0336-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • SevereNHTSA·16V810000·2016-11-08

    Newmar Recalls 2017 Motorhomes Due to Throttle Circuit Wire Interference

    Newmar is recalling 51 model year 2017 motorhomes because throttle circuit wires may not be twisted, potentially causing unintended acceleration or deceleration.

    Product
    NEWMAR — NEWMAR LONDON AIRE, MOUNTAIN AIRE, KING AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V812000·2016-11-08

    Hyundai Translead Recalls 2012-2013 HT Trailers Due to Cracking I-Beams

    Hyundai Translead is recalling 892 model year 2012-2013 HT trailers because I-beams may crack, potentially causing the bogie to detach and increasing crash risk.

    Product
    HYUNDAI TRANSLEAD — HYUNDAI TRANSLEAD HT HYCUBE, HT ORIGINAL, HT COMPOSITE-XT, HT COMPOSITE
    Category
    Vehicle
    Distribution
    Distributed nationwide