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.

11826–11850 of 29163

  • SevereFDA (Food)·F-1478-2019·2019-06-26

    APS BioGroup Recalls Immuno PRP Spray Due to Bacterial Contamination

    APS BioGroup is recalling Immuno PRP Spray because testing found elevated levels of Stenotrophomonas maltophilia. The product was distributed nationwide and in Switzerland.

    Product
    Immuno PRP Spray, UPC 8 12527 01176 2. Colostrum Polypeptides. 5 fl oz (140 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1480-2019·2019-06-26

    APS BioGroup Recalls DPS Throat Spray Due to Bacterial Contamination

    APS BioGroup is recalling DPS Throat Spray because testing found elevated levels of Stenotrophomonas maltophilia bacteria.

    Product
    DPS Throat Spray, UPC 8 55602 00021 3. Colostrum Immune Concentrate. Net 150 ml
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1829-2019·2019-06-26

    Covidien EGIA 60 Articulating Medical Stapler Recall for Missing Pins

    FDA is recalling 3,113,280 units of the EGIA 60 Articulating Medical Stapler due to missing pin components that may cause incomplete staple formation and serious surgical complications.

    Product
    EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1408-2019·2019-06-26

    P & L Developments Recalls Cetirizine Oral Solution Due to Bacterial Contamination

    P & L Developments, LLC is recalling 17,664 bottles of Cetirizine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1832-2019·2019-06-26

    Recall of Signia Tri-Staple 2.0 Surgical Reloads Due to Missing Pins

    Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, potentially leading to serious surgical complications.

    Product
    SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1443-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.125 mg due to cross-contamination caused by cleaning failures.

    Product
    Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1490-2019·2019-06-26

    Whole Foods Sun-Dried Tomato Pesto Recalled for Undeclared Allergens

    Whole Foods Market is recalling sun-dried tomato pesto because the labels failed to declare milk, walnuts, and pine nuts.

    Product
    Sun-dried tomato pesto, sold by weight in plastic deli containers PLU code beginning with 256009
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1409-2019·2019-06-26

    P & L Developments Recalls Cetirizine Oral Solution Due to Bacterial Contamination

    P & L Developments is recalling 124,512 bottles of Up & Up Children's Cetirizine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1440-2019·2019-06-26

    Zydus Recalls Anastrozole Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Anastrozole tablets due to cross-contamination from cleaning failures. The recall covers 1.4 million bottles distributed nationwide.

    Product
    ANASTROZOLE — ANASTROZOLE (ANASTROZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1472-2019·2019-06-26

    Renaissance Food Group Recalls 365 by Whole Foods Yellowfin Tuna Salad

    Renaissance Food Group LLC is recalling 365 by Whole Foods Yellowfin Tuna Salad due to undeclared soy. The recall covers 144 units sold in Texas, Louisiana, and Oklahoma.

    Product
    365 by Whole Foods Yellowfin Tuna Salad packaged in a clear plastic clamshell 8 Oz. UPC 81641602120
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1833-2019·2019-06-26

    Recall of Signia Tri-Staple 2.0 Reloads Due to Missing Pin Components

    Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, leading to serious surgical complications.

    Product
    SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1828-2019·2019-06-26

    FDA Recalls Covidien EGIA 60 Articulating Extra Thick Sulu Devices

    The FDA is recalling 3,113,280 units of the EGIA 60 Articulating Extra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious surgical complications.

    Product
    EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1826-2019·2019-06-26

    Covidien EGIA 45 Articulating Medical Stapler Recall for Missing Pins

    FDA is recalling 3.1 million EGIA 45 staplers due to missing pins that may cause incomplete stapling and serious surgical complications.

    Product
    EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1836-2019·2019-06-26

    Signia Tri-Staple Surgical Device Recalled Due to Missing Pin Components

    The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.

    Product
    SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1835-2019·2019-06-26

    Recall of Signia Tri-Staple Surgical Devices Due to Missing Pin Components

    Covidien LLC is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, potentially leading to serious surgical complications.

    Product
    SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1469-2019·2019-06-26

    Renaissance Food Group Recalls Tuna Salad Wraps for Undeclared Soy

    Renaissance Food Group is recalling 365 by Whole Foods Market Classic Tuna Salad Wraps due to undeclared soy. The recall covers 84 units sold in Texas, Louisiana, and Oklahoma.

    Product
    365 by Whole Foods Market Classic Tuna Salad Wrap packaged in a clear cellophane 7.75 Oz. UPC 81641602250
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·19V493000·2019-06-26

    Subaru Recalls 2019 Legacy and Outback for Body Strength Defect

    Subaru is recalling 2019 Legacy and Outback vehicles because improperly applied spot welds may reduce body strength, increasing injury risk in a crash.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1825-2019·2019-06-26

    FDA Recalls Covidien EGIA 30 Articulating Medical Devices

    The FDA is recalling 3,113,280 units of the EGIA 30 Articulating Medical device due to missing pin components that may cause incomplete staple formation and serious surgical complications.

    Product
    EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1831-2019·2019-06-26

    FDA Recalls 3.1 Million Covidien Surgical Staplers Due to Missing Pins

    The FDA is recalling 3,113,280 units of EGIA45 CT AR MD THK REL surgical staplers because missing pin components may cause incomplete staple formation, leading to serious surgical complications.

    Product
    EGIA45 CT AR MD THK REL, EGIA45CTAMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2019·2019-06-26

    FDA Recalls Signia Tri-Staple 2.0 Devices Due to Missing Pin Components

    The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.

    Product
    SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1407-2019·2019-06-26

    P & L Developments Recalls Cetirizine HCL Oral Solution Due to Contamination

    P & L Developments, LLC is recalling 202,068 bottles of Cetirizine HCL Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.
    Category
    Drug
    Distribution
    Distributed nationwide