The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

9126–9150 of 29156

  • SevereFDA (Devices)·Z-3052-2020·2020-10-07

    ESAOTE AC/DC Power Supply Recall for Portable Ultrasound Systems

    ESAOTE is recalling AC/DC power adapters for specific portable ultrasound systems because the connector may heat up, smoke, or melt due to mechanical stress.

    Product
    AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (1017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0004-2021·2020-10-07

    FDA Recalls Endo GIA Stapler Loading Units Due to Staple Formation Defect

    The FDA is recalling specific lots of Endo GIA Auto Suture Universal Articulating Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0025-2021·2020-10-07

    Blumen Aloe Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    4e Brands North America is recalling Blumen Aloe Advanced Hand Sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor manufacturing practices.

    Product
    blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0002-2021·2020-10-07

    Sun Pharmaceuticals Recalls RIOMET ER Due to NDMA Impurity

    Sun Pharmaceuticals is recalling RIOMET ER (metformin hydrochloride) oral suspension because it contains the impurity NDMA.

    Product
    RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V618000·2020-10-07

    Lamborghini Recalls 2020 Aventador SVJ Models for Suspension Bolt Issue

    Lamborghini is recalling 2020 Aventador SVJ Coupe and Roadster vehicles because loose front suspension anchor bolts may cause a loss of vehicle control.

    Product
    LAMBORGHINI — LAMBORGHINI AVENTADOR SVJ ROADSTER, AVENTADOR SVJ COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1551-2020·2020-10-07

    Spokane Produce Potato Salad Recalled for Salmonella Newport Risk

    Spokane Produce, Inc. is recalling refrigerated potato salad containing onion supplied by Thomson International, Inc. due to a Salmonella Newport risk.

    Product
    Item 80698 Potato Salad, Refrigerated, net wt. 9 OZ, packaged in Cardboard Box.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0045-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,253 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. This defect could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3053-2020·2020-10-07

    ESAOTE Portable Ultrasound AC/DC Power Supply Recall for Overheating Risk

    ESAOTE is recalling AC/DC power supplies for specific portable ultrasound systems because the connector may heat up, generate smoke, and melt.

    Product
    AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (1017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0008-2021·2020-10-07

    Endo GIA Stapler Recall Due to Incomplete Staple Formation

    FDA recalls Endo GIA Auto Suture staplers because staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0031-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,264 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0022-2021·2020-10-07

    Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    4e Brands North America is recalling Blumen Advanced Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination.

    Product
    blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamer
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·21004·2020-10-07

    CB2 Recalls Bordo Dining Tables Due to Collapse Hazard

    CB2 is recalling Bordo and Bordo XL dining tables because the legs can become unsteady, causing the table to collapse and posing an injury hazard.

    Product
    Bordo and Bordo XL dining tables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0048-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb Fast Braided Absorbable Sutures due to a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0032-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,268 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1585-2020·2020-10-07

    Spokane Produce Recalls Pico De Gallo Salsa Due to Salmonella Risk

    Spokane Produce, Inc. is recalling two items of refrigerated Pico De Gallo Salsa Hot because they contain onion supplied from Thomson International, Inc. that may be contaminated with Salmonella Newport.

    Product
    Item 83985 Pico De Gallo Salsa Hot, Refrigerated, net wt. 8 OZ, packaged in Plastic Container. Item 83986 Pico De Gallo Salsa Hot Saddlin' Up, Refrigerated, net wt. 16 OZ, packaged in Plastic Container.
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·20V614000·2020-10-06

    Ferrari Recalls 812 Superfast Vehicles for Rear Window Adhesion Defect

    Ferrari is recalling 2018-2020 812 Superfast vehicles because the rear window may have been bonded incorrectly, potentially leading to detachment and increased crash risk.

    Product
    FERRARI — FERRARI 812 SUPERFAST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V607000·2020-10-02

    Mercedes-Benz Recalls 2020 GLC 350e for High-Voltage Wiring Harness Defect

    Mercedes-Benz is recalling 2020 GLC 350e hybrid vehicles because a high-voltage wiring harness shield may fail, causing an electrical malfunction and vehicle stall.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLC 350 E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V610000·2020-10-02

    Micro Bird Recalls 2019 MB II Buses Due to Electrical Fire Risk

    Micro Bird is recalling 75 model-year 2019 MB II buses because a grounding wire issue may cause a short circuit, increasing the risk of fire.

    Product
    MICRO BIRD — MICRO BIRD MB II SCHOOL BUS, MB II TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V603000·2020-10-01

    GM Recalls 2018 Trucks and SUVs for Brake Assist Defect

    General Motors is recalling 2018 Cadillac, Chevrolet, and GMC vehicles because a vacuum pump issue can reduce power brake assist, increasing stopping distance.

    Product
    CHEVROLET — CHEVROLET, CADILLAC, GMC SILVERADO 1500, ESCALADE, TAHOE, SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0006-2021·2020-09-30

    Toufayan Bakery Recalls Gluten-Free Animal Crackers Due to Undeclared Wheat

    Toufayan Bakery, Inc. is recalling Goodie Girl Gluten Free Magical Animal Crackers because the product was mixed with wheat-containing product, resulting in undeclared wheat.

    Product
    Goodie Girl, Gluten Free Magical Animal Crackers, 7 ounce , paper cartons, 6 packages per case, Best By JAN 11 21 A3
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1586-2020·2020-09-30

    Leafree Hand Sanitizer Recalled for Lacking FDA Approval

    Corgiomed LLC is recalling Leafree Instant Hand Sanitizer because it was marketed without FDA approval and labeled as edible alcohol.

    Product
    Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, Mc
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-1544-2020·2020-09-30

    Gilster-Mary Lee Recalls Organic Microwave Popcorn Due to Glass Contamination

    Gilster-Mary Lee Corp. is recalling specific brands of organic microwave popcorn because tempered glass pieces were found in the product.

    Product
    Microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Salted, 3-2.9 oz (82 g) bags, Net Wt. 8.7 oz (247 g), Distributed by Topco Associates LLC, Elk Grove Villiage, IL, UPC 36800-40611 2) Sprouts Farmers Market, Organic Salted Microwave
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-1623-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations

    Preferred Pharmaceuticals is voluntarily recalling specific lots of Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    2 states