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.

20626–20650 of 32121

  • SevereNHTSA·16E018000·2016-03-07

    ZF Front Control Arm Recall Due to Potential Tube Separation

    ZF Group is recalling specific front control arms where a manufacturing defect may cause the tube to separate from the shaft, potentially leading to loss of vehicle control.

    Product
    SUSPENSION:FRONT:CONTROL ARM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·023-2016·2016-03-05

    Perdue Recalls Applegate Chicken Nuggets Due To Plastic Contamination

    Perdue Foods is recalling Applegate Naturals Chicken Nuggets due to possible plastic contamination. No illnesses have been reported.

    Product
    Gold Creek Foods, LLC — Perdue Foods LLC, Recalls Chicken Nugget Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·16V131000·2016-03-04

    Prevost Recalls X3-45 Buses Due to Cracking Passenger Seat Frames

    Prevost is recalling 2015-2016 X3-45 buses because cracks in sliding passenger seats may compromise structural integrity, increasing injury risk in crashes.

    Product
    PREVOST — PREVOST X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V133000·2016-03-04

    Prevost Recalls Coaches Due to Fuel Line Fire Risk

    Prevost is recalling specific 2011-2016 coach models because a missing clip allows the coolant line to rub against the fuel hose, potentially causing a fuel leak and engine compartment fire.

    Product
    PREVOST — PREVOST H3-41, H3-45, H3-VIP, X3-VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V127000·2016-03-03

    Toyota and Lexus Recall for Front Passenger Air Bag Inflator Rupture Risk

    Toyota is recalling specific 2008-2010 Lexus SC, Corolla, Corolla Matrix, and Pontiac Vibe vehicles because the front passenger air bag inflator may rupture during deployment.

    Product
    LEXUS — LEXUS, TOYOTA, PONTIAC SC, COROLLA MATRIX, COROLLA, VIBE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0799-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Central Venous Catheter Sets

    Cook Inc. is recalling 1,341 single-lumen central venous catheter sets and trays due to a manufacturing defect that may cause catheter tip fracture or separation.

    Product
    Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0921-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 326 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0798-2016·2016-03-02

    Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Splits

    Cook Inc. is recalling 9,519 Shuttle Select Slip-Cath Catheters worldwide due to reports of catheter tip splits and separation, which can cause loss of function or complications.

    Product
    Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0827-2016·2016-03-02

    Draeger Medical Recalls Evita and Babylog Ventilators Due to Battery Defect

    Draeger Medical is recalling Evita Infinity V500 and Babylog Infinity VN500 ventilators because the optional PS500 power supply unit batteries may discharge prematurely despite showing adequate charge.

    Product
    Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0935-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 189 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0634-2016·2016-03-02

    Fresh Express Chopped Romaine Lettuce Recalled for Undeclared Allergens

    Fresh Express is recalling Club Size Chopped Romaine Lettuce because it contains undeclared milk, eggs, wheat, and fish.

    Product
    Fresh Express, Club Size, Chopped Romaine Lettuce, 32 oz., in clear flexible plastic bags, containing condiments in a separate clear flexible plastic bag.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0800-2016·2016-03-02

    Cook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture

    Cook Inc. is recalling 2,280 single-lumen pressure monitoring sets and trays because a manufacturing defect may cause catheter tips to fracture or separate.

    Product
    Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0802-2016·2016-03-02

    Cook Inc. Recalls Radial Artery Pressure Monitoring Catheter Sets

    Cook Inc. is recalling radial artery pressure monitoring catheter sets because a manufacturing defect may cause the catheter tip to fracture or separate.

    Product
    Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0632-2016·2016-03-02

    Mahina Mele Farm Recalls Raw Macadamia Nut Butter for Salmonella

    Mahina Mele Farm is recalling Baby Bruddah's Chocolate Mac Nut Buttah because samples tested positive for Salmonella.

    Product
    Baby Bruddah's Chocolate Mac Nut Buttah; Certified Organic by International Certification Services Inc. From the Big Island, A raw food. Sold in 12 oz. plastic tub. UPC number: 75318224204 Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·16E017000·2016-03-02

    Bergstrom Air Conditioner Recall for Fire Risk in Freightliner Trucks

    Bergstrom is recalling ParkSmart HVAC units for Freightliner Cascadia trucks due to a connector defect that may cause overheating and increase the risk of a fire.

    Product
    EQUIPMENT:APPLIANCE:AIR CONDITIONER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0633-2016·2016-03-02

    Roundy's Recalls Butternut Squash Ravioli for Undeclared Cashews and Almonds

    Roundy's is recalling Simply Roundy's Butternut Squash Ravioli because it may contain undeclared cashews and almonds. The product was distributed in Illinois and Wisconsin.

    Product
    Simply Roundy's Natural Authentic Italian Butternut Squash Ravioli, Net Wt. 9 oz (255g). Packaged in a paper tray inside a plastic bag and wrapped around with paper band. Made in Italy. UPC 11150-50750
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0975-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0992-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 126 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0981-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0629-2016·2016-03-02

    Mahina Mele Farm Recalls Izzie Macs! Macadamia Nuts Due to Salmonella Risk

    Mahina Mele Farm is recalling Izzie Macs! Macadamia Nuts because samples tested positive for Salmonella. Consumers should stop eating the product and return it to the store.

    Product
    Izzie Macs! Macadamia Nuts - Unsalted. Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 6 oz. plastic bag and 16 oz. plastic bag. UPC - 6 oz.: 689076793575; UPC 16 oz.: 689076792776. Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0801-2016·2016-03-02

    Cook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling specific femoral artery pressure monitoring catheter sets and trays because a manufacturing defect may cause the catheter tip to fracture or separate.

    Product
    Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0930-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 34 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents when disconnected.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide