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.

17401–17425 of 29217

  • SevereFDA (Food)·F-0157-2017·2016-10-26

    Union Bagel Shop Recalls Sourdough Bagels Due to Undeclared Wheat

    Union Bagel Shop is recalling sourdough bagels because they contain undeclared wheat. The products were sold at one retail store in Grande, Oregon.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Sour Dough: Flour, Filtered Water, Olive Oil, Organic Shortening, Malt, Sugar, Sea Salt, Sourdough Start.***" 2 bagels per package - plastic bag with twist tie.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0260-2017·2016-10-26

    Windstone Medical Packaging Recalls Peri Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 115 Peri Kits (PSS1037) because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0215-2017·2016-10-26

    Fresh From Texas Recalls HEB Sliced Red Apples With Caramel Dip

    Fresh From Texas Inc. is recalling HEB Ready Fresh Go Sliced Red Apples With Caramel Dip due to potential Listeria monocytogenes contamination.

    Product
    HEB Ready Fresh Go Sliced Red Apples With Caramel Dip 16 oz UPC 4122079830 packaged in clear plastic bag
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0191-2017·2016-10-26

    QualiTech Dry Blueberry and Strawberry Blend Recalled for E. coli O121 Risk

    QualiTech is recalling 40,080 lbs of dry blueberry and strawberry blend due to potential E. coli O121 contamination.

    Product
    FI Dry Blueberry / Strawberry Blend, Product Code 21585. 40 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0141-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0274-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0189-2017·2016-10-26

    Birdy 3 in 1 Coffee Mix Recalled for Undeclared Milk Allergen

    Food Gusto, Inc. is recalling Birdy 3 in 1 Robusta Coffee Mix because it may contain undeclared milk and has unclear nutritional labeling.

    Product
    Birdy 3 in 1 Robusta Coffea Mix, 445.5 g in a red sealed plastic bag, Product of Thailand, UPC 8850250007425
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·16V777000·2016-10-26

    Ford Recalls 2010-2012 Escape and 2010-2011 Mariner for Fuel Leak Risk

    Ford is recalling specific 2010-2012 Escape and 2010-2011 Mariner vehicles because a cracked fuel delivery module may cause a fuel leak, increasing the risk of fire.

    Product
    FORD — FORD, MERCURY ESCAPE, MARINER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0212-2017·2016-10-26

    Del Monte Recalls Cut Green Beans Due to Crawfish Parts

    Del Monte is recalling cut green beans and field peas with snaps due to a customer complaint of finding crawfish parts in the product.

    Product
    Cut Green Beans packed under brand names of: Allens Cut Green Beans (Ejotes Cortados Lago Azul) Blue Lake . Allens Cracker Barrel Label (Both labels have same UPC # - different sodium content - 140 mg for Allens Cut Green Beans and 250 for Cracker Barrel label Peso Neto…
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Food)·F-0208-2017·2016-10-26

    QualiTech Recalls PE Blueberries Due to Potential E. coli O121 Contamination

    QualiTech is recalling 176,900 lbs of PE Blueberries due to potential E. coli O121 contamination. The product was distributed to multiple US states and Canada.

    Product
    PE Blueberry, Product Code 27136. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0005-2017·2016-10-26

    Heartware Ventricular Assist System Controller Recall for Loose Connector Ports

    Heartware, Inc. is recalling Ventricular Assist System Controllers due to loose connector ports. The recall affects 4,235 units worldwide, including 7,272 in the U.S.

    Product
    HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0213-2017·2016-10-26

    Del Monte Recalls Field Peas and Green Beans Due to Crawfish Parts

    Del Monte is recalling approximately 15,000 cases of canned field peas and green beans after a customer complaint reported finding crawfish parts in the product.

    Product
    Allens East Texas Fair Brand, Tiny Tender Field Peas with snaps; NET.WT. 6 lbs. 15 oz.. (3.15kg) UPC 0 34700 623214 8 Distributed by Sager Creek Vegetable Company, Siloam Springs, AR 72761-0250 USA; UPC 0 34700 63213 1
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Devices)·Z-0055-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass Dual Access Catheters Due to Manufacturing Residue

    Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the catheter tip or within the distal rapid exchange lumen.

    Product
    Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V778000·2016-10-26

    Ford Recalls 2017 F-Series Trucks Due to Fuel Leak Fire Risk

    Ford is recalling 2017 F-250 through F-550 Super Duty trucks because a fuel shield may detach, causing a leak that increases fire risk.

    Product
    FORD — FORD F-550 SD, F-350 SD, F-450 SD, F-250 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0218-2017·2016-10-26

    Fresh From Texas Recalls Deluxe Fruit Tray for Listeria Risk

    Fresh From Texas Inc. is recalling 18,392 units of Deluxe Fruit Tray 52 oz. due to potential Listeria monocytogenes contamination.

    Product
    Deluxe Fruit Tray 52 oz. UPC 427979661 packaged in clear plastic round container
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0106-2017·2016-10-26

    Dream Body Extreme Gold Recalled for Undeclared Sibutramine

    Dream Body Weight Loss is recalling Dream Body Extreme Gold capsules because they contain undeclared sibutramine and were marketed without FDA approval.

    Product
    Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0180-2017·2016-10-26

    Windstone Medical Packaging Recalls Endoscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 304 Endoscopy Packs because disposable gloves in the kits may have splits or holes that compromise sterility.

    Product
    Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0107-2017·2016-10-26

    Dream Body Weight Loss Capsules Recalled for Undeclared Sibutramine

    Dream Body Weight Loss is recalling Dream Body 450 mg capsules because they contain undeclared sibutramine and were marketed without FDA approval.

    Product
    Dream Body 450 mg 30 capsules in a plastic screw on top bottle
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0290-2017·2016-10-26

    RTI Surgical Recalls Streamline OCT Spinal Rods Due to Cracks

    RTI Surgical is voluntarily recalling 66 units of Streamline OCT spinal rods due to potential cracks that could reduce strength and cause patient injury.

    Product
    RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0224-2017·2016-10-26

    Fresh From Texas Recalls HEB Ready Fresh Go Carrots and Apples

    Fresh From Texas Inc. is recalling HEB Ready Fresh Go Carrots and Apples due to potential Listeria monocytogenes contamination.

    Product
    HEB Ready Fresh Go Carrots, Apples with Yogurt Pretzels and Ranch Dip 4.75 oz. UPC 4122002119 packaged in clear plastic tray
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0216-2017·2016-10-26

    Fresh From Texas Recalls Apples for Listeria Contamination Risk

    Fresh From Texas Inc. is recalling 34,425 units of packaged apples in Texas due to potential Listeria monocytogenes contamination.

    Product
    Red & Green Apples Large 17 oz. UPC 4122087649 packaged in clear plastic container
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0223-2017·2016-10-26

    Fresh From Texas Recalls HEB Ready Fresh Go Carrots and Apples

    Fresh From Texas Inc. is recalling HEB Ready Fresh Go Carrots, Apples with Sesame Sticks & Hummus due to potential Listeria monocytogenes contamination.

    Product
    HEB Ready Fresh Go Carrots, Apples with Sesame Sticks & Hummus 6 oz. UPC 4122002144 packaged in clear plastic tray
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0185-2017·2016-10-26

    Windstone Medical Packaging Recalls Extremity Tray Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 816 Extremity Tray kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0127-2017·2016-10-26

    X Spine Systems Recalls Calix T PEEK Lumbar System Trial Devices

    X Spine Systems is recalling 1,186 Calix T PEEK Lumbar System trial devices because components may detach and lodge in the intervertebral space during surgery.

    Product
    Calix T PEEK Lumbar System, TLIF Trial
    Category
    Medical Device
    Distribution
    19 states