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.

9076–9100 of 29123

  • SevereFDA (Food)·F-1619-2020·2020-10-07

    365 Organic Reduced Fat Popcorn Recalled for Glass Contamination

    Eagle Family Foods is recalling 365 Organic Reduced Fat Popcorn because pieces of glass may be present in the product.

    Product
    365 Whole Foods Market Organic Reduced fat &Sodium Popcorn, 6 oz. bag, UPC 099482435349, 10 retail units per wholesale case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0030-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,262 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 4/0 Undyed 30" P-14, Product Number: SVP2251, UDI: 20884521177380 - 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 u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0007-2021·2020-10-07

    FDA Recalls Endo GIA Auto Suture Units Due to Staple Formation Defects

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

    Product
    Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - 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-0026-2021·2020-10-07

    ASSURED Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    4e Brands North America is recalling ASSURED Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination, representing poor CGMPs.

    Product
    ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10 fL oz / 296 ml bottle, UPC 6 39277 49069 8, Distributed by Geenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mex
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0044-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,266 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 infections.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - 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 liga
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2021·2020-10-07

    Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

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

    Product
    blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands No
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0028-2021·2020-10-07

    Modesa Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    4e Brands North America is recalling Modesa hand sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor manufacturing practices.

    Product
    Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7
    Category
    Drug
    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 (Food)·F-1560-2020·2020-10-07

    Spokane Produce Recalls Epicurean Greek Salad Kits Due to Salmonella Risk

    Spokane Produce, Inc. is recalling Epicurean Greek Salad Kits because they contain onion supplied from Thomson International, Inc., which is associated with Salmonella Newport.

    Product
    Item 80631, Epicurean Greek Salad Kit, Refrigerated, net wt. 8.4 LB, packaged in Cardboard Box.
    Category
    Food
    Distribution
    5 states
  • 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
  • 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 (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
  • 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 (Drugs)·D-0032-2021·2020-10-07

    Losartan Pot/HCTZ 50/12.5 mg Recalled Due to Impurity Detection

    Direct Rx is recalling 33 bottles of Losartan Pot/HCTZ 50/12.5 mg tablets distributed in Florida due to trace amounts of impurity NMBA.

    Product
    Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
    Category
    Drug
    Distribution
    1 state
  • 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 (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-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 (Food)·F-1553-2020·2020-10-07

    Spokane Produce Recalls Parisian Kale Salad Kits Due to Salmonella Risk

    Spokane Produce, Inc. is recalling refrigerated Parisian Kale Salad Kits because they contain onion supplied from Thomson International, Inc. that may be contaminated with Salmonella Newport.

    Product
    Item 80194 Parisian Kale Salad Kit, Refrigerated, net wt. 4.25 LB, packaged in Cardboard Box.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1578-2020·2020-10-07

    Spokane Produce Recalls Fresh Medium Salsa Due to Salmonella Newport Risk

    Spokane Produce, Inc. is recalling 8-ounce containers of Fresh Medium Salsa because the product contains onion supplied by Thomson International, Inc., which is associated with Salmonella Newport.

    Product
    Item 84023 Fresh Medium Salsa, Refrigerated, net wt. 8 OZ, packaged in Plastic Container.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1612-2020·2020-10-07

    Spokane Produce Recalls Stew Mix Trays Due to Salmonella Newport Risk

    Spokane Produce, Inc. is recalling refrigerated stew mix trays because they contain onion supplied from a source associated with Salmonella Newport.

    Product
    Item 80849 Stew Mix Trays, Refrigerated, net wt. 24 OZ, packaged in Plastic Container. Label does not have cooking instructions.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1602-2020·2020-10-07

    Spokane Produce Recalls Unlabeled Diced Onions for Salmonella Newport

    Spokane Produce, Inc. is recalling unlabeled diced onions distributed in the Pacific Northwest and Mountain West due to a Salmonella Newport contamination risk.

    Product
    Item 79000 Onion Yellow Diced, Refrigerated, net wt. 5 LB, packaged in Sealed Plastic Bag. No label. Item 79007 Onion Yellow Diced, Refrigerated, net wt. 2 LB, packaged in Sealed Plastic Bag. No label. Item 79001 Onion Yellow Diced, Refrigerated, net wt. 5 LB, packaged
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1562-2020·2020-10-07

    Spokane Produce Recalls Trifecta Delight Salad Kit Due to Salmonella Risk

    Spokane Produce is recalling Trifecta Delight Salad Kits because they contain onion supplied by Thomson International, Inc., which is associated with Salmonella Newport.

    Product
    Item 80201 Trifecta Delight Salad Kit, Refrigerated, net wt. 9 LB, packaged in Cardboard Box.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1570-2020·2020-10-07

    Spokane Produce Recalls Chicken Salad Sandwiches Due to Salmonella Risk

    Spokane Produce, Inc. is recalling refrigerated chicken salad sandwiches because they contain onion supplied by a source linked to Salmonella Newport.

    Product
    Item 79800 Chicken Salad Sandwich, Refrigerated, net wt. 5.5 OZ, packaged in Plastic Container.
    Category
    Food
    Distribution
    5 states