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.

18876–18900 of 32108

  • 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
  • SevereFDA (Food)·F-0199-2017·2016-10-26

    QualiTech Red Bell Pepper Recalled for Potential E. coli O121 Contamination

    QualiTech is recalling 4,150 lbs of red bell peppers due to potential E. coli O121 contamination. The product was distributed in ten US states and Canada.

    Product
    FE Red Bell Pepper, Product Code 22708. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0195-2017·2016-10-26

    QualiTech Recalls Green Bell Peppers Due to Potential E. coli O121 Contamination

    QualiTech, Inc. is recalling 300 lbs of green bell peppers due to potential E. coli O121 contamination. The product was distributed to multiple US states and Canada.

    Product
    FE Green Bell Pepper 338, Product Code 22338. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0233-2017·2016-10-26

    Windstone Medical Packaging Recalls Major Laparotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 12 Major Laparotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0108-2017·2016-10-26

    Dream Body Advanced capsules recalled for undeclared sibutramine

    Dream Body Advanced 400 mg capsules are being recalled because they contain undeclared sibutramine and were marketed without an approved NDA/ANDA.

    Product
    Dream Body Advanced 400 mg 30 capsules in brown foil packets.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0126-2017·2016-10-26

    X Spine Systems Recalls Calix T PEEK Lumbar System TLIF Rasps

    X Spine Systems is recalling 195 units of Calix T PEEK Lumbar System TLIF Rasps because the tools may detach and become lodged in the surgical site.

    Product
    Calix T PEEK Lumbar System, TLIF Rasp
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-0203-2017·2016-10-26

    QualiTech Recalls Frozen Red Bell Peppers Due to E. coli O121 Risk

    QualiTech is recalling frozen red bell peppers due to a potential presence of E. coli O121 bacteria reported by a supplier.

    Product
    FE RedBell Pepper, Product Code 22760. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0225-2017·2016-10-26

    Fresh From Texas Recalls HEB Fruit Cups for Listeria Risk

    Fresh From Texas Inc. is recalling HEB Ready Fresh Go fruit cups due to potential Listeria monocytogenes contamination. The product was distributed in Texas.

    Product
    HEB Ready Fresh Go Pineappple, Grapes & Apples with Banana Chips 6 oz. UPC 4122002138 packaged in clear plastic tray
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0198-2017·2016-10-26

    QualiTech Recalls Cheddar Cheese Due to Potential E. coli O121 Presence

    QualiTech is recalling FE Cheddar Cheese because a supplier reported the potential presence of E. coli O121 bacteria.

    Product
    FE Cheddar Cheese, Product Code 22518. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0146-2017·2016-10-26

    Fresh Express American Salad Recalled for Incorrect Condiment Kits

    Fresh Express is recalling American Salad bags that may contain incorrect condiment kits. Consumers in six states should check their products.

    Product
    Fresh Express American Salad, 11 oz., Product Code G264A12B, Use-By Date OCT 05
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0263-2017·2016-10-26

    Windstone Medical Recalls Plastic Packs with Defective Gloves

    Windstone Medical Packaging is recalling 204 plastic packs used in general surgery because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0219-2017·2016-10-26

    Fresh From Texas Recalls Apples and Grapes Due to Listeria Risk

    Fresh From Texas Inc. is recalling 10-ounce packages of Apples & Grapes sold in Texas due to potential Listeria monocytogenes contamination.

    Product
    Apples & Grapes 10 oz. UPC 4122087666 packaged in clear plastic container
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0162-2017·2016-10-26

    Union Bagel Shop Cowboy Cookies Recalled for Undeclared Allergens

    Union Bagel Shop is recalling Cowboy Cookies In-a-Jar because the packaging fails to declare wheat, milk, and soy allergens.

    Product
    Package contains a business card for "***BAGEL SHOP***" "***Cowboy Cookies In-a- Jar***INGREDIENTS: FLOUR, ROLLED OATS, BROWN SUGAR, BAKING POWDER, SALT, SUGAR, M & M's***" This information was hand written on a business card, no separate ingredient statement.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0202-2017·2016-10-26

    QualiTech Recalls Green Bell Peppers Due to E. coli O121 Risk

    QualiTech, Inc. is recalling specific lots of green bell peppers due to a potential presence of E. coli O121 bacteria identified by a supplier.

    Product
    FE Green Bell Pepper, Product Code 22733. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0206-2017·2016-10-26

    QualiTech Recalls FE Bacon Due to Potential E. coli O121 Presence

    QualiTech, Inc. is recalling 500 lbs of FE Bacon because a supplier notified them of potential E. coli O121 bacteria in the material.

    Product
    FE Bacon, Product Code 24117. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0201-2017·2016-10-26

    QualiTech Recalls FE Rainbow Blend 714 Due to E. coli O121 Risk

    QualiTech is recalling FE Rainbow Blend 714 because a supplier notified them of potential E. coli O121 bacteria contamination.

    Product
    FE Rainbow Blend 714, Product Code 22714. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0196-2017·2016-10-26

    QualiTech Recalls Red Bell Peppers Due to Potential E. coli O121

    QualiTech is recalling 6,000 lbs of red bell peppers due to potential E. coli O121 contamination. The product was distributed to 10 US states and Canada.

    Product
    FE RedBell Pepper 339, Product Code 22339. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0124-2017·2016-10-26

    Kabobs Recalls Mini Cheese Quiche Due to E. coli O121 Contamination

    Kabobs Inc is recalling 377 cases of Mini Cheese Quiche because the flour used was contaminated with E. coli O121. The product was distributed across 28 states.

    Product
    MINI CHEESE QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Devices)·Z-0253-2017·2016-10-26

    Windstone Medical Recalls Ortho Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 145 Ortho Kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0163-2017·2016-10-26

    Fred Meyer Recalls Boar's Head Superfood Wraps for Undeclared Allergens

    Fred Meyer is recalling Boar's Head To Go Superfood Wraps sold in deli departments due to undeclared milk, soybeans, wheat, and cashews.

    Product
    Product is refrigerated Boars Head To Go (BTG) Superfood Wrap, sold at deli department. The wraps are made in store and the weight varies and they are sold as one each (wrap). The UPC is 41573 11053.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0134-2017·2016-10-26

    Kabobs Four Cheese Puff Recalled Due to E. coli O121 Contamination

    Kabobs Inc is recalling Four Cheese Puff products because they were manufactured with flour contaminated with E. coli O121.

    Product
    FOUR CHEESE PUFF, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260
    Category
    Food
    Distribution
    27 states
  • SevereNHTSA·16E079000·2016-10-25

    Atwood Recalls Left Side Seat Adjusters for Crash Safety Non-Compliance

    Atwood Mobile Products is recalling specific left side seat adjusters used in vehicle seat belts because they may allow seats to move during a crash, increasing injury risk.

    Product
    SEAT BELTS:FRONT:ANCHORAGE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide