The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

651–675 of 4878

  • SevereFDA (Food)·F-1789-2024·2024-09-04

    Yummy Swirly Ices Popsicles Recalled for Undeclared Milk Allergen

    Yummy brand Swirly Ices Tropical Tornado popsicles are recalled due to undeclared milk. The recall affects 275 boxes distributed to retail supermarkets in nine states.

    Product
    Yummy brand Swirly Ices Tropical Tornado flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007567. Also packaged in 30 count packs
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2602-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tubes Recalled for Defective Securement Flange

    Smiths Medical is recalling PORTEX Bivona neonatal and pediatric tracheostomy tubes worldwide due to a manufacturing defect in the securement flange that may tear and affect proper positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUB
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1758-2024·2024-09-04

    Nuts.com Paprika Recalled for Possible Salmonella Contamination

    Nuts.com is recalling 25-pound bags of paprika due to possible Salmonella contamination. Affected product was distributed to consignees in Virginia and Massachusetts.

    Product
    Nuts.com Paprika 25 lb, packaged in a clear plastic bag. 1 bag per cardboard box.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2599-2024·2024-09-04

    Tracheostomy Tubes Recalled Due to Securement Flange Tears

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. These tubes are used for neonatal, pediatric, and adult patients worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2591-2024·2024-09-04

    PORTEX Bivona Neonatal Tracheostomy Tubes recalled for defective securement flange

    Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect in the securement flange, which may tear. Affected patients should discontinue use and contact their healthcare provider.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2605-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled for Potential Securement Flange Failure

    Smiths Medical recalled specific lots of Bivona Tracheostomy Tubes after identifying a manufacturing defect that may cause the securement flange to tear, risking tube displacement.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE ,
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2607-2024·2024-09-04

    Bivona Neonatal Tracheostomy Tubes recalled due to defective securement flanges

    Smiths Medical recalls specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes due to manufacturing defects in the securement flange that may tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1793-2024·2024-09-04

    Popsicle Recall: Yummy Brand Swirly Ices Contain Undeclared Milk

    Yummy brand Swirly Ices popsicles are recalled due to undeclared milk allergen. The recall affects 282 boxes distributed across nine states.

    Product
    Yummy brand Swirly Ices Assorted Flavors Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC: 734690007574. Contains Fruity Melon, Churning Cherry, Berry Blast, and Tropical Tornado flavored popsicles
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2589-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled Due to Securement Flange Tear Risk

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because a manufacturing defect may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Produc
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·23V285000·2024-09-04

    2021-2024 Thor Motor Coach Motorhomes Recalled for Fuel Hose Defect

    Thor Motor Coach is recalling approximately 2,919 motorhomes with fuel hose clamps that may lack adequate clamping force, risking gasoline leaks and fires. Owners should contact dealers for free fuel hose and clamp replacement.

    Product
    THOR MOTOR COACH — 2021 THOR MOTOR COACH SCOPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2615-2024·2024-09-04

    PORTEX Bivona Neonatal and Pediatric Tracheostomy Tubes Recalled for Flange Tear

    Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes because the securement flange may tear due to a manufacturing defect.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRAC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2603-2024·2024-09-04

    Tracheostomy Tubes Recalled for Manufacturing Defect Affecting Securement Flange

    Smiths Medical recalled specific lots of PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products were distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1750-2024·2024-09-04

    Prime Food Steam Buns Recalled for Undeclared Sesame Allergen

    Prime Food brand steam buns may contain undeclared sesame, an allergen not listed on the product label. The FDA classified this as a Class I recall affecting 477 cases across multiple U.S. states and international locations.

    Product
    Prime Food brand Steam Bun with Egg Custard & Coconut Added; 10pcs/pack; NET WT. 20 oz (1lb.4 oz) 568g; KEEP FROZEN; INGREDIENTS: Dough: Bleached Wheat Flour, Water, Sugar, Salad Oil (Soybean Oil, Canola Oil), Food Starch-Modified, Instant Yeast (Yeast (Saccharomyces Cerevisiae),
    Category
    Food
    Distribution
    27 states
  • SevereNHTSA·24V097000·2024-09-02

    2021-2022 Ford E-350 and E-450 Power Steering Fluid Loss Recall

    Ford is recalling certain 2021-2022 E-350 and E-450 vehicles due to a defective power steering connection that may cause loss of power steering fluid and brake assist.

    Product
    FORD — 2021 FORD E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24352·2024-08-29

    Glow in Dark Party Supplies Toy Sets Recalled for Battery Ingestion Hazard

    Glow in Dark Party Supplies Toy Sets sold on Amazon contain button cell batteries in Bunny Ears Headbands that can be easily accessed by children, posing a serious ingestion hazard. The sets violate federal battery-operated toy regulations.

    Product
    Glow in Dark Party Supplies Toy Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1788-2024·2024-08-28

    Meijer Dunking Cookies Recalled for Undeclared Milk Allergen

    Meijer Inc is recalling Meijer Dunking Cookies Chocolate Chip (10 oz) due to undeclared milk. The product poses a risk to consumers with milk allergies.

    Product
    MEIJER DUNKING COOKIES CHOCOLATE CHIP, 10oz in clear plastic container. UPC 7-13733-71297-2
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0641-2024·2024-08-28

    Acetaminophen Aspirin Caffeine Tablets Recalled for Missing Drug Facts Labels

    Aurohealth LLC is recalling Acetaminophen, Aspirin and Caffeine tablets because some bottles are missing the manufacturer's label containing drug facts information. Affected product was distributed in NJ, NY, and PA.

    Product
    ACETAMINOPHEN ASPIRIN AND CAFFEINE — ACETAMINOPHEN ASPIRIN AND CAFFEINE (ACETAMINOPHEN, ASPIRIN AND CAFFEINE)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0638-2024·2024-08-28

    FDA Class I Recall: B. Braun Sodium Chloride Injection for Particulate Matter

    B. Braun Medical Inc. is recalling 63,444 containers of 0.9% Sodium Chloride Injection USP nationwide due to the presence of particulate matter. This intravenous medication may pose a serious health risk if administered to patients.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2637-2024·2024-08-28

    McGRATH MAC EMS Video Laryngoscope Battery Management System Recall

    Covidien is recalling McGRATH MAC EMS Video Laryngoscopes due to a battery management system defect that may deplete below design specifications, creating risk of thermal events and explosion. About 10,449 units were distributed worldwide.

    Product
    McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2587-2024·2024-08-28

    ClotTriever XL Catheter instructions updated to prevent device entrapment and embolism

    Inari Medical has updated instructions for the ClotTriever XL Catheter (30 mm) to prevent device entrapment and pulmonary embolism. Approximately 2,488 units distributed worldwide are affected.

    Product
    ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0635-2024·2024-08-28

    FDA Recalls Acetaminophen Injection Due to Labeling Mix-up

    Hikma Pharmaceuticals is recalling Acetaminophen Injection because bags of Dexmedetomidine HCl were found packaged inside Acetaminophen-labeled overWraps. The error could result in patients receiving the wrong intravenous medication.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    2 states
  • SevereCPSC·24347·2024-08-22

    Head Rush Technologies TRUBLUE Speed Auto Belay Devices Fall Hazard

    Head Rush Technologies is recalling about 220 TRUBLUE Speed Auto Belay Devices because the backup brake can fail to activate, posing a fall hazard and risk of serious injury or death. Consumers should immediately stop using the devices and contact the manufacturer for a free inspection and repair.

    Product
    TRUBLUE Speed Auto Belay Devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2448-2024·2024-08-21

    Plum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect

    ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1740-2024·2024-08-21

    North Fish USA Recalls Cold Smoked Capelin Due to Botulism Risk

    North Fish USA is recalling Cold Smoked Capelin packages due to potential Clostridium botulinum contamination in uneviscerated fish. The affected products were distributed in Georgia and New York.

    Product
    Cold Smoked Capelin, 9-ounce packages, plastic trays, 34 packages per case (Best By Date:07.13.2024), 18 packages per case (Best Buy Date: 01.05.2025), UPC code4811527003360, Keep Frozen,UPC code 4811527003360
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1728-2024·2024-08-21

    Foppen Smoked Norwegian Salmon Slices Recalled for Potential Listeria Contamination

    Foppen Smoked Norwegian Salmon Slices (8.1oz vacuum foil packages) are recalled due to potential contamination with Listeria monocytogenes. The recall affects 747 cases distributed across 15 U.S. states.

    Product
    Foppen Smoked Norwegian Salmon Slices - Toast Size, packaged in 8.1oz vacuum foil, packaged within cardboard envelope. Keep Refrigerated at 38F or below.
    Category
    Food
    Distribution
    15 states