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.

25351–25375 of 32194

  • SevereFDA (Food)·F-2170-2014·2014-07-16

    Surma Distributors Recalls Golden Raisins Due to Undeclared Sulfites

    Surma Distributors LLC is recalling HAQUE brand Golden Raisins because they contain undeclared sulfites, which can cause serious or life-threatening allergic reactions in sensitive individuals.

    Product
    HAQUE brand GOLDEN RAISINS, WT 7 OZ. --- SURMA DISTRIBUTORS LLC Brooklyn, NY 11237 --- Nutrition Facts: Serving Size 1/4 tsp (0.5 g), Servings 204
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·14V425000·2014-07-14

    Aston Martin Recalls 2014 DB9 and Rapide S for Transmission Defect

    Aston Martin is recalling 440 model year 2014 DB9 and Rapide S vehicles because a faulty circuit board may cause the transmission to shift to neutral without driver input.

    Product
    ASTON MARTIN — ASTON MARTIN DB9, RAPIDE S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E037000·2014-07-10

    Airtex E84070 Replacement Fuel Pumps Recalled for Leak Risk

    UCI-Fram Group is recalling Airtex E84070 replacement fuel pumps shipped between December 2013 and June 2014 due to a seal defect that may cause fluid leaks and increase fire risk.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1923-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-2056-2014·2014-07-09

    Whole Foods Recalls Fresh Wild Gulf Amberjack Due to Illness Complaints

    Whole Foods Market South Seafood Distribution is recalling fresh wild Gulf Amberjack in Georgia after receiving complaints of illness from consumers.

    Product
    Fresh Wild Gulf Amberjack (Whole, Fillet and Portion)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2057-2014·2014-07-09

    Lao Thai Nam Salted Fish Recalled for Botulism Risk

    Lao Thai Nam Corporation is recalling 120 packs of Number One Sompa Salted Fish due to potential Clostridium botulinum contamination. The product was distributed in Texas.

    Product
    Lao Thai Nam Number One Sompa Salted Fish, Net Wt 7 oz. (198 g), Produced by Lao Thai Nam, 4444 W. Illinois Ave., Ste 400a, Dallas, TX 75211, UPC 8 84332 00019 4
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2068-2014·2014-07-09

    Rite Aid Recalls Thrifty Mint 'N' Chip Ice Cream Due to Undeclared Pistachio

    Rite Aid is recalling 560 pints of Thrifty Mint 'N' Chip ice cream because pistachio was inadvertently packed into the containers without being declared on the label.

    Product
    waxed paperboard int container of frozen ice cream labeled Thrifty Ice Cream Mint 'N' Chip 1 Pint (16 Fl. OZ.) Bottom of container Expiration Date: October 28 2015 Lot #24273 Back of container UPC 1182264327
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1920-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may disconnect from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1978-2014·2014-07-09

    Stryker Triathlon Patella Inserter Recalled for Instrument Fracture Risk

    Stryker Howmedica Osteonics is recalling 22 units of the Triathlon Tritanium Patella Inserter because the instrument may fracture during implantation.

    Product
    Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1985-2014·2014-07-09

    Siemens Mobilett XP X-ray System Recalled for Fire Hazard

    Siemens is recalling 10 Mobilett XP Digital Mobile X-ray Systems due to a potential fire hazard from Lithium-Ion batteries installed between October 2010 and April 2011.

    Product
    Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1922-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1989-2014·2014-07-09

    GE Healthcare Recalls Revolution XR/d X-ray Systems Due to Collimator Fall Risk

    GE Healthcare is recalling Revolution XR/d digital radiographic systems because a collimator installation error during maintenance could cause the device to fall and injure patients.

    Product
    GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1948-2014·2014-07-09

    Ventlab Manual Resuscitator Bags Recalled Due to Valve Defect

    Ventlab LLC is recalling 251,384 manual resuscitator bags because a defective pop-off valve may prevent air delivery during emergency resuscitation.

    Product
    Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2053-2014·2014-07-09

    Baptista's Bakery Recalls Gluten-Free Crackers Due to Salmonella Risk

    Baptista's Bakery is recalling specific lots of Rosemary & Olive Oil Gluten Free Snack Crackers because a seasoning supplier's blend may be contaminated with Salmonella.

    Product
    Rosemary & Olive Oil Gluten Free Snack Crackers sold under the following brand names and sizes: 1. glutino, Net Wt. 4.25 oz (120g) UPC 78523-03861; 2. glutino, 2 count 10 oz bags, Net Wt. 20 oz (566 g) UPC 78523-03863; 3. Aldi's brand live G free, Net Wt. 4.25 oz (120g)…
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1921-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may disconnect from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1959-2014·2014-07-09

    Atrium Express Dry Seal Chest Drain Recall Due to Leaking Risk

    Atrium Medical Corporation is recalling 1,170 units of the Express Dry Seal Chest Drain ATS Blood Recovery because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1924-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1988-2014·2014-07-09

    GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Collimator Fall Risk

    GE Healthcare is recalling Proteus XR/a and Revolution XR/d X-ray systems due to a collimator installation error that caused a serious patient injury.

    Product
    GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1991-2014·2014-07-09

    Siemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur TnI-Ultra assay kits because a darker solid phase reagent in some lots may lead to incorrect test results.

    Product
    ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1981-2014·2014-07-09

    Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk

    Vascular Solutions is recalling Langston Dual Lumen Catheters because the inner catheter may separate from the hub during use, potentially requiring intervention to prevent injury.

    Product
    Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2078-2014·2014-07-09

    Dole Garden Soup Recalled for Undeclared Milk Allergen

    Dole Packaged Foods is recalling Roasted Garlic Tomato Basil soup because it contains undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Dole Garden Soup "Roasted Garlic Tomato Basil", Net Wt. 26 oz. (1lb 10oz) 737 g, UPC 3890002404, 6 units/case
    Category
    Food
    Distribution
    4 states