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.

17426–17450 of 29217

  • 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 (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-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 (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-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-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-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
  • SevereUSDA FSIS·100-2016·2016-10-25

    Crider Recalls Canned Organic Roasted Chicken Breast Due to Foreign Matter

    Crider Inc. is recalling approximately 5,610 pounds of canned Organic Roasted Chicken Breast due to possible foreign matter contamination.

    Product
    Crider, Inc. — Crider Inc. Recalls Canned Organic Roasted Chicken Breast Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V772000·2016-10-24

    Jayco Recalls 2017 Eagle Fifth Wheel Trailers for Axle Defect

    Jayco is recalling specific 2017 Eagle fifth wheel trailers due to axles with insufficient load capacity, which may lead to tire failure and increased crash risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V769000·2016-10-24

    ARBOC Spirit of Liberty Recall for Engine Run Lockout Wiring Defect

    ARBOC is recalling 2016 Spirit of Liberty vehicles because improper wiring may allow the engine to start while a mechanic is working on it, posing a risk of injury or death.

    Product
    ARBOC — ARBOC SPIRIT OF LIBERTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·099-2016·2016-10-21

    St. Clair Foods Recalls Chicken and Dumplings for Undeclared Milk Allergen

    St. Clair Foods is recalling approximately 26,800 pounds of chicken and dumplings due to misbranding and an undeclared milk allergen. The products were distributed to food service warehouses in six states.

    Product
    St. Clair Foods Inc. — St. Clair Foods, Inc. Recalls Poultry Products Due To Misbranding And An Undeclared Allergen
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·16V765000·2016-10-21

    Navistar Recalls School Buses with Defective Wheelchair Lifts

    Navistar is recalling certain 2015-2017 IC Bus school buses equipped with specific Ricon wheelchair lifts. The defect may cause the lift platform to fall out of the vehicle, increasing injury risk.

    Product
    IC BUS — IC BUS RESB, CESB, CASB, AE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V764000·2016-10-21

    Kaufman Recalls 2015-2016 Mini Car Haulers Due to Spring Defect

    Kaufman is recalling 2015-2016 Mini Car Haulers because a spring eye may break, allowing the axle to slide and potentially causing a crash.

    Product
    KAUFMAN — KAUFMAN MINI CAR HAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2017·2016-10-19

    Pharmedium Recalls Heparin Sodium Syringes Due to Subpotency and Stability Concerns

    Pharmedium Services, LLC is recalling 350 syringes of Heparin Sodium Injection USP because confirmed subpotency and stability data do not support the expiry date.

    Product
    HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0016-2017·2016-10-19

    Leiter's Compounding Recalls Moxifloxacin Intravitreal Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Moxifloxacin intravitreal injections because they were produced using recalled filters, raising concerns about sterility.

    Product
    Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
    Category
    Drug
    Distribution
    Distributed nationwide