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.

16276–16300 of 29206

  • SevereFDA (Food)·F-1754-2017·2017-04-05

    Cumberland Valley Creamery Recalls Unlabeled Chevre for E. coli

    Cumberland Valley Creamery is recalling unlabeled Chevre cheese in Maryland and Pennsylvania because laboratory tests found E. coli levels exceeding allowed limits.

    Product
    Chevre unlabeled, Manufactured for repacking and relabeling.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1788-2017·2017-04-05

    Cookies Nezhakomka Recalled for Undeclared Milk Allergen

    Kusher LLC is recalling Cookies Nezhakomka because the label fails to declare milk, a major allergen, despite the product containing butter.

    Product
    COOKIES NEZHAKOMKA, product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ), UPC: 8 51929 00366 1. The label is read in parts: "***COOKIES "NEZNAKOMKA" *** INGREDIENTS: WHEAT FLOUR (FLOUR, NIACIN, IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID)…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1749-2017·2017-04-05

    Cumberland Valley Creamery Recalls Harvarti Cheese for E. coli Contamination

    Cumberland Valley Creamery is recalling Luqman Cheese and Dutchland Homestead Harvarti cheeses because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Luqman Cheese Harvarti, Net Wt. 8 oz., Distributed by Cumberland Valley Creamery; Mechanicsburg, PA; OR Dutchland Homestead Harvarti, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1803-2017·2017-04-05

    Lipari Old Tyme Muenster Cheese Recalled for Listeria Risk

    Lipari Foods is recalling Old Tyme Muenster Cheese due to potential Listeria monocytogenes contamination from a supplier.

    Product
    Lipari Old Tyme Muenster Cheese, 12/8 oz.
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0622-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Institutional, Inc. is recalling 1,527 cartons of Atorvastatin Calcium 10 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1613-2017·2017-04-05

    FDA Recalls 216 Custom Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 216 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-1778-2017·2017-04-05

    Fuji Food Products Recalls Hawaiian Delight for Potential Listeria

    Fuji Food Products is recalling 180 cases of Hawaiian Delight (4.5 lb) due to a potential Listeria monocytogenes contamination. The product was distributed in California.

    Product
    Hawaiian Delight, Net Wt. 4.5lb
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1699-2017·2017-04-05

    Stryker Visum LED Surgical Lighting System Recalled for Mounting Defect

    Stryker is recalling 292 Visum LED Surgical Lighting systems because missing screws and user overloading may cause the equipment to fall.

    Product
    The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1785-2017·2017-04-05

    Kusher LLC Recalls Princesa Cookies Due to Undeclared Milk Allergen

    Kusher LLC is recalling Princesa cookies because the label fails to declare milk, a major allergen, despite the product containing butter.

    Product
    COOKIES "PRINCESA", product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ). UPC: 8 51929 00359 3 The label is read in parts: "***COOKIES "PRINCESA" *** INGREDIENTS: WHEAT FLOUR (WHEAT FLOUR, NIACIN, REDUCE IRON, THIAMINE MONONITRATE, RIBOFLAVIN…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1816-2017·2017-04-05

    Baidyanath Brahmi Bati Recalled for Heavy Metal Contamination

    Butala Emporium is recalling Baidyanath brand Brahmi Bati dietary supplements because they contain lead, mercury, and/or arsenic at levels exceeding permissible limits.

    Product
    Baidyanath brand Brahmi Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-0615-2017·2017-04-05

    Claris Lifesciences Recalls Levofloxacin Injection Due to Sterility Concerns

    Claris Lifesciences Inc. is recalling Levofloxacin Injection due to a potential leak that may compromise sterility. The recall covers 24,456 units distributed nationwide.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0613-2017·2017-04-05

    Claris Ciprofloxacin Injection Recalled for Potential Sterility Breach

    Claris Lifesciences Inc. is recalling Ciprofloxacin in Dextrose Injection due to a potential leak that may compromise sterility.

    Product
    Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0614-2017·2017-04-05

    Claris Fluconazole Injection Recalled for Potential Sterility Breach

    Claris Lifesciences is recalling Fluconazole Injection due to a potential leak that could compromise sterility and contaminate the product.

    Product
    Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V228000·2017-04-04

    McNeilus Refuse Trucks and Mixers Recalled for CNG Fitting Defect

    McNeilus is recalling 2014-2016 refuse trucks and mixers with Cummins CNG engines due to an incorrect fitting that may cause a gas leak, fire, or engine stall.

    Product
    MCNEILUS — MCNEILUS BRIDGEMASTER V MIXER, STANDARD MIXER, REFUSE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V225000·2017-03-31

    Ford Recalls 2017 F-250 Super Duty Trucks Due to Transmission Defect

    Ford is recalling 2017 F-250 Super Duty trucks because a damaged transmission part may cause unexpected vehicle movement while in Park, increasing crash risk.

    Product
    FORD — FORD F-250 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V224000·2017-03-31

    Kia Recalls 2011-2014 Models Due to Engine Bearing Wear Risk

    Kia is recalling 2011-2014 Optima, Sorento, and Sportage vehicles because machining errors may cause premature engine bearing wear, potentially leading to engine seizure and increased crash risk.

    Product
    KIA — KIA SPORTAGE, SORENTO, OPTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V223000·2017-03-31

    KME Predator Fire Trucks Recalled for Front Suspension Ball Joint Defect

    KME is recalling certain Predator fire trucks because front suspension ball joints can loosen, potentially causing a loss of steering control.

    Product
    KME — KME PREDATOR PUMPER, PREDATOR SS AERIAL, PREDATOR AERIAL, PREDATOR SS PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V221000·2017-03-31

    Yamaha Recalls 2015-2017 Motorcycles for Handlebar Holder Defect

    Yamaha is recalling 22,433 motorcycles because the lower handlebar holder may loosen, potentially causing a loss of vehicle control.

    Product
    YAMAHA — YAMAHA XSR900, FJ-09, FZ-09
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1705-2017·2017-03-29

    MDS Foods Recalls Mozzarella Cheese Due to Listeria Contamination

    MDS Foods Inc is recalling specific lots of Deli Made EZ Mozzarella St Pk .75oz Slice because a sample tested positive for Listeria monocytogenes.

    Product
    Mozzarella Cheese packaged as: (a) Deli Made EZ Mozzarella St Pk .75oz Slice, Item 11553, 1.5 lbs, UPC 828653105558
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-1674-2017·2017-03-29

    Sesame Seed Recall Issued for Potential Botulism Contamination

    Dukarani Food Processing is recalling Benniseed natural sesame seeds due to potential Clostridium botulinum contamination.

    Product
    Benniseed, Natural sesame seeds, Vita and fish, Net Weight: 8 oz. Packed by: Dukarani Food Processing, Inc., 1729 Lyndale Ave. North, Mpls, MN 55411. Storage: Keep in cool dry place.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1706-2017·2017-03-29

    MDS Foods Recalls Provolone Cheese Due to Listeria Contamination Risk

    MDS Foods Inc is recalling specific lots of Provolone Cheese because a sample tested positive for Listeria monocytogenes. The recall covers products distributed across 16 states.

    Product
    Provolone Cheese packaged as: (a) Santino Deli Made EZ Provolone St Pck .75oz Slice, Item 58554, 1.5 lbs, UPC 828828653585541 (b) Deli Made EZ Provolone St Pck .5oz Slice, Item 58555, 1.5 lbs, UPC 828653585558 (c) Duck Deli Provolone Stk Pck .75oz Slice, Item 58747, 1.5…
    Category
    Food
    Distribution
    15 states