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.

25126–25150 of 32194

  • SevereFDA (Food)·F-2399-2014·2014-09-03

    Beta Labs Recalls Phentylene Dietary Supplement Containing DMAA

    Beta Labs is recalling Phentylene capsules because they contain DMAA, a substance not permitted in dietary supplements.

    Product
    PHENTALENE (TM), PHARMACEUTICAL GRADE, With 50 mg of Ephedra Extract, 90 CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599822
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2391-2014·2014-09-03

    Tiny Isle Fudge Pack Recalled for Potential Salmonella Contamination

    Tiny Isle Fudge Pack is being recalled because it was made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Fudge Pack, Organic-Raw- Gluten Free: Mint Crunch, Mac Nut Fudge, Lava Fudge, 5-oz. Tiny Isle 4505 Kukui St. 20A Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2378-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles are being recalled because they were made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Chocolate Truffles: Gluten Free, Raw, Vegan; Sold in 4 pack box - 4 oz: Flavors: Sea Salt, Coconut, Macadamia Nut, Mint Crunch Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2539-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereNHTSA·14V527000·2014-09-03

    Western Star 4900 Trucks Recalled for Missing Anti-lock Brake Systems

    Daimler Trucks North America is recalling 2014-2015 Western Star 4900 trucks manufactured without Anti-lock Brake Systems, which increases the risk of wheel lockup and crashes.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2384-2014·2014-09-03

    Tiny Isle Lava Fudge Recalled for Potential Salmonella Contamination

    Tiny Isle Lava Fudge is being recalled because it contains carob powder that may be contaminated with Salmonella.

    Product
    Tiny Isle Lava Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder, nioi chili's, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2541-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kit Tube Holders

    Smiths Medical ASD, Inc. is recalling H4052 Endo Tube Holders because the fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Food)·F-2394-2014·2014-09-03

    Health Matters America Recalls Sprouted Chia Seed Powder for Salmonella Risk

    Health Matters America Inc. is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder and related products due to possible Salmonella contamination.

    Product
    ORGANIC SPROUTED DARK SPROUTED CHIA SEED POWDER BULK; NET WT. 50 lb; item number BLK548
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Drugs)·D-1566-2014·2014-09-03

    Pharmakon Recalls Midazolam IV Bags Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl IV bags because they contain undeclared benzyl alcohol.

    Product
    Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715.…
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-2385-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles Kauai Coconut are being recalled because they were made with carob powder potentially contaminated with Salmonella.

    Product
    Tiny Isle Chocolate Truffles Kauai Coconut: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2390-2014·2014-09-03

    Tiny Isle Fudge Mix Recalled for Potential Salmonella Contamination

    Florimont, Inc. is recalling Tiny Isle Fudge Mix Organic due to potential Salmonella contamination in the carob powder used.

    Product
    Tiny Isle Fudge Mix Organic, Organic-Raw- Gluten Free; Cacao powder, carob powder, Hawaiian sea salt. Tiny Isle 4505 Kukui St. 20A Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2536-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Food)·F-2388-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles Mint Crunch are being recalled due to potential Salmonella contamination in the carob powder used to make them.

    Product
    Tiny Isle Chocolate Truffles Mint Crunch: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2400-2014·2014-09-03

    Beta Labs Recalls PHEnFX Dietary Supplement Containing Unapproved DMAA

    Beta Labs is recalling 743 units of PHEnFX dietary supplements because they contain DMAA, a substance not permitted in dietary supplements.

    Product
    PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559802
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2540-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Compression

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Food)·F-2393-2014·2014-09-03

    Organic Traditions Sprouted Chia and Flax Seed Powder Recalled for Salmonella

    Health Matters America Inc. is voluntarily recalling Organic Traditions Sprouted Chia and Flax Seed Powder due to possible Salmonella contamination.

    Product
    ORGANIC TRADITIONS SPROUTED CHIA & FLAX SEED POWDER; NET WT. 8 oz., 16 oz and 50 lbs, UPC 854260006216, item AHM621, UPC 854260005479, item number AHM547 and item number BLK622
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-2383-2014·2014-09-03

    Tiny Isle Mint Crunch Fudge Recalled for Potential Salmonella Contamination

    Tiny Isle Mint Crunch Fudge is being recalled because it was made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Mint Crunch Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder cacao nibs, mint, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2387-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles Macadamia Nut are being recalled because they were made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Chocolate Truffles Macadamia Nut: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2381-2014·2014-09-03

    Tiny Isle Coconut Fudge Recalled for Potential Salmonella Contamination

    Tiny Isle Coconut Fudge is being recalled because it was made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Coconut Fudge, 2-oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,coconut, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2537-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereCPSC·14750·2014-09-03

    Great Innovations Recalls Ultrasonic Humidifiers Due to Fire Hazard

    Great Innovations is recalling about 70,000 Ultrasonic Clean Mist Humidifiers sold by QVC because water can enter the base and cause a fire hazard.

    Product
    Ultrasonic Clean Mist Humidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2401-2014·2014-09-03

    Beta Labs Recalls Red Vipers Supplement Containing Illegal DMAA

    Beta Labs is recalling Red Vipers dietary supplements because they contain DMAA, an ingredient not permitted in dietary supplements.

    Product
    RED VIPERS, ADVANCED FOCUS AND CONCENTRATION, HEIGHTENED ENERGY LEVELS, 75mg EPHEDRA, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559819
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2538-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states