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.

4826–4850 of 4878

  • SevereFDA (Drugs)·D-0628-2021·2021-06-23

    Imperia Elita Vitaccino Coffee Recalled for Unapproved Drug Ingredients

    Imperia Elita Vitaccino Coffee sachets are being recalled because they were marketed without FDA approval and contain pharmaceutical ingredients Sibutramine and Fluoxetine. All lots distributed nationwide are affected.

    Product
    Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1860-2021·2021-06-23

    Medtronic Angiographic Guidewire Components Shipped Without Required Sterilization

    Medtronic Vascular recalled 54,997 angiographic guidewire components that were shipped directly to customers without the required downstream processing and sterilization. The components should have been sent to a third-party processor first.

    Product
    Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use fo
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Food)·F-0667-2021·2021-06-23

    Olde Thompson and Sun Harvest Organic Coriander Recalled for Salmonella

    Olde Thompson and Sun Harvest are recalling 1.5oz. jars of organic ground coriander due to potential Salmonella contamination. Affected lots are 23631 and 23632 with best-before dates of 05/2023.

    Product
    Olde Thompson Organic Ground Coriander 1.5oz. in glass jar with flip-top lid. Sun Harvest Organic Coriander 1.5oz in glass jar with flip-top lid. UPC code: 400000290942 Olde Thompson item numbers: 1901-43, 1901-43CA, 1901-43SU
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1784-2021·2021-06-16

    Adult Chest Tube Tray Recalled Due to Package Integrity Risk

    Avid Medical is recalling 130 Adult Chest Tube Trays due to potential contamination from mold growth in a component. The BD ChloraPrep applicator may grow Aspergillus penicillioides, which could breach package integrity and contaminate other kit components.

    Product
    ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1539-2021·2021-06-16

    COVID-19 Self-Test Kit Distributed Without Clinical Investigation Authorization

    Innova Medical Group recalled COVID-19 self-test kits distributed to customers outside of clinical investigation requirements. About 1,206 tests in 402 boxes were distributed across the U.S., Canada, India, and the United Kingdom.

    Product
    COVID-19 Self-Test Kit *** INNOVA *** 3T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1537-2021·2021-06-16

    FDA Recalls Innova COVID-19 Self-Test Kits Due to Unauthorized Distribution

    Innova Medical Group is recalling COVID-19 self-test kits distributed to customers outside an authorized clinical investigation. The recall affects 370 boxes of tests distributed nationwide and internationally.

    Product
    COVID-19 Self-Test Kit *** INNOVA *** 7T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1787-2021·2021-06-16

    Dialysis access kits recalled for potential fungal contamination risk

    Avid Medical is recalling medical dialysis access kits due to potential fungal growth in an applicator component that may compromise the package seal and contaminate other components. Approximately 560 kits distributed nationwide are affected.

    Product
    DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1833-2021·2021-06-16

    DeRoyal Heart Cath Procedure Packs Recalled for Anesthetic Mislabeling

    DeRoyal Industries is recalling 66 heart catheterization procedure packs due to mislabeling of anesthetic contents. The packs contain 0.5% Bupivacaine but are labeled as containing 1% Lidocaine, creating a medication error risk during surgery.

    Product
    DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2021·2021-06-16

    Surgical procedure pack anesthetic mislabeled with wrong drug and strength

    DeRoyal Angio Cath Removal Tray contains mislabeled anesthetic; the label indicates 1% Lidocaine but the tray actually contains 0.5% Bupivacaine. This FDA Class I recall affects 60 trays distributed in MS, VA, LA, and NY.

    Product
    DeRoyal Angio Cath Removal Tray, REF 89-9936.02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0748-2021·2021-06-16

    Enoki Mushroom Recalled for Listeria monocytogenes Contamination

    Rainfield Marketing Group is recalling 150g packages of Enoki Mushroom (UPC 085412004020) because samples tested positive for Listeria monocytogenes. The product was distributed to California, Texas, and Maryland.

    Product
    Enoki Mushroom, 150g clear plastic bag with orange bottom; UPC 085412004020 Product of Korea Do no consume Raw Distributed by Rainfield Marketing Group
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1538-2021·2021-06-16

    INNOVA SARS-CoV-2 Antigen Rapid Tests Recalled for Unauthorized Non-Clinical Distribution

    INNOVA Medical Group is recalling SARS-CoV-2 antigen rapid test kits distributed to customers not enrolled in an authorized clinical investigation.

    Product
    For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1798-2021·2021-06-16

    Jelco Insulin Syringe Graduation Markings Recalled for Skew Defect

    Smiths Medical recalls 1,432,200 Jelco insulin syringes with skewed graduation markings that could lead to incorrect dosing. Specific lot numbers are affected.

    Product
    JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0659-2021·2021-06-16

    Organic Microwave Butter Popcorn Recall Due to Undeclared Milk

    Gilster-Mary Lee Corp. is recalling Organic Microwave Butter Popcorn because butter microwave popcorn bags were packaged in organic salted popcorn consumer boxes, resulting in undeclared milk in the product. The recall affects 413 cases distributed to multiple states.

    Product
    Organic Microwave Butter Popcorn in cartons labeled to be Organic Microwave Popcorn Salted, Net Wt 8.7 OZ, Distributed by TOPCO Associates LLC Elk Grove, IL, UPC 0 36800 40611 7
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0673-2021·2021-06-16

    BC Foods AD Celery Stalk Products Recalled for Salmonella

    BCFoods, Inc. is recalling certain BC Foods AD Celery Stalk products because an ingredient tested positive for Salmonella. The affected products are sold in bulk fiber cartons to food service and manufacturing customers.

    Product
    BC Foods AD Celery Stalk Canners, 25 lb. Poly lined bulk fiber carton, item code VCES-TCA-BJA-AA-AB; BC Foods AD Celery Stalk Cross Cut, 25 lb. Poly lined bulk fiber carton, item code VCES-TC9-BQS-AC-AB; BC Foods AD Celery Stalk Cross Cut, 25 lb. Poly lined bulk fiber carton, it
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1832-2021·2021-06-16

    DeRoyal Pacemaker Tray Mislabeled With Wrong Anesthetic Concentration

    DeRoyal is recalling surgical procedure packs due to mislabeling. The product contains 0.5% Bupivacaine but is labeled as 1% Lidocaine, creating a medication identification error.

    Product
    DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0674-2021·2021-06-16

    BC Foods Celery Stalk and Leaf Dice Recalled for Salmonella

    BC Foods is recalling Celery Stalk and Leaf Dice due to an ingredient testing positive for Salmonella. The product was distributed to food manufacturers and distributors across eight states.

    Product
    BC Foods Celery Stalk and Leaf Dice 3/8, AD Sulfites, 11 lb. Poly lined bulk fiber carton. Item code: VCE1-D38-AXG-AB-AR
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0664-2021·2021-06-16

    Hy-Vee Chicken Street Taco Kit Recalled for Undeclared Egg Allergen

    Hy-Vee is recalling Chicken Street Taco kits because the chipotle crema component contains undeclared egg, a major food allergen. The product was distributed to Hy-Vee stores across multiple states.

    Product
    Hy-Vee Chicken Street taco kit, Net Wt. 18 OZ, UPC 282503 212993.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1785-2021·2021-06-16

    Avid Medical Fistula On-Off Kit Recalled for Potential Fungal Contamination

    Avid Medical is recalling 720 Fistula On-Off Kits due to potential fungal contamination that may compromise package integrity. The BD ChloraPrep applicator component may develop Aspergillus penicillioides, which could contaminate other kit components.

    Product
    FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V715000·2021-06-11

    Keystone Outback trailers recalled for potential frame rail buckling defect

    Keystone is recalling 2019–2021 Outback recreational trailers for inadequate frame rail support that may cause buckling and crash risk. Owners should contact 1-866-425-4369 for the free frame reinforcement repair.

    Product
    KEYSTONE — 2019 KEYSTONE OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0646-2021·2021-06-09

    Giant Eagle Chicken Street Taco Kit recalled for undeclared egg allergen

    Giant Eagle is recalling Chicken Street Taco Kit packages due to undeclared egg allergen. The affected product was distributed to stores in PA, WV, OH, and IN.

    Product
    Giant Eagle Chicken Street Taco Kit; 20 oz (1 lbs 4 oz) Individual Units, PLU Code beginning 256598 00000
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0626-2021·2021-06-09

    Bupivacaine and Lidocaine Injection Vials Recalled for Label Mix-Up

    Pfizer is recalling 163,957 vials of 0.5% Bupivacaine Hydrochloride Injection due to a label mix-up where some vials labeled as bupivacaine may contain lidocaine, and vials labeled as lidocaine may contain bupivacaine. The mix-up could lead to patients receiving the wrong local anesthetic.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1620-2021·2021-06-09

    Leccurate SARS-CoV-2 Antigen Test Kit Recalled: Not FDA-Approved for U.S. Distribution

    The Leccurate SARS-CoV-2 Antigen Rapid Test Kit is being recalled because it was not authorized, cleared, or approved for marketing in the United States. Approximately 8.4 million units were distributed worldwide, including to U.S. states and territories.

    Product
    Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Food)·F-0645-2021·2021-06-09

    Peppa Pig Chocolate Chip Cookies Recalled for Undeclared Egg Allergen

    PRIMARY COLORS DESIGN CORP is recalling Peppa Pig brand chocolate chip cookies due to undeclared egg allergen on the packaging. The recall affects 294 boxes distributed in Georgia, lot number 091820.

    Product
    Peppa Pig brand chocolate chip cookies. One 7 oz bag per box- 6 boxes per case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1619-2021·2021-06-09

    Leccurate COVID-19 Antibody Test Kit Recalled for Unauthorized U.S. Distribution

    LEPU Medical has recalled the Leccurate SARS-CoV-2 Antibody Rapid Test Kit because it is not authorized, cleared, or approved for marketing in the U.S. Approximately 8.4 million units have been distributed worldwide.

    Product
    Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adapti
    Category
    Medical Device
    Distribution
    4 states
  • SevereCPSC·21150·2021-06-09

    Klein Tools Non-Contact Voltage Tester Recalled for Shock Hazard

    Klein Tools non-contact voltage testers (model NCVT-1) are recalled because the on/off button can fail to disengage, causing the tester to malfunction and potentially fail to detect live voltage. One shock injury has been reported.

    Product
    Klein Tools Non-Contact Voltage Tester Model NCVT-1
    Category
    Consumer Product
    Distribution
    Distributed nationwide