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.

901–925 of 4878

  • SevereFDA (Food)·F-1304-2024·2024-06-05

    Hy-Vee cookies and cream mix products recalled due to Salmonella

    Hy-Vee Stores Inc is recalling Hy-Vee To Go and Hy-Vee Cookies & Cream Mix products due to potential Salmonella contamination. Affected products were distributed in eight Midwest states.

    Product
    Hy-Vee To Go Cookies & Cream Mix, Net wt. 4 oz (113g), UPC 0075450486740, 6 containers per case. Hy-Vee Cookies & Cream Mix, Net Wt. 16oz (453g), UPC 0075450486730, 6 containers per case.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1876-2024·2024-06-05

    Medline Sub-G Endotracheal Tubes with Subglottic Suctioning—Inflation and Suction Defects

    Medline endotracheal tubes with subglottic suctioning may have inflation tubes that detach or tear and suction pumps that disconnect, risking loss of ventilation control.

    Product
    Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID; (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID; (5) REF DYNJ18880, Po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1274-2024·2024-06-05

    Gibson Farms Organic Nuts Recalled for Potential E. Coli Contamination

    Gibson Farms Organic Nuts – Light Halves and Pieces are recalled due to potential E. coli O157:H7 contamination. Affected lots 3325-043 and 3341-501 were distributed to California and Washington.

    Product
    Gibson Farms Organic Nuts -Light Halves and Pieces
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1817-2024·2024-05-29

    Philips OmniLab Advanced + Ventilator May Experience Unexpected Therapy Loss

    Philips OmniLab Advanced + Ventilators may experience an alarm condition that interrupts or stops therapy delivery. This interruption may lead to inadequate breathing support, low oxygen levels, and potentially fatal respiratory failure.

    Product
    OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1812-2024·2024-05-29

    BiPAP V30 Auto Ventilator May Interrupt Therapy During Malfunction Alarm

    Philips BiPAP V30 Auto Ventilators may interrupt or lose therapy during a Ventilator Inoperative alarm, potentially causing hypoventilation, severe oxygen depletion, or respiratory failure.

    Product
    BiPAP V30 Auto Ventilator, Part Number 1111178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1814-2024·2024-05-29

    BiPAP A30 Ventilator Recall: Risk of Therapy Interruption and Respiratory Failure

    Philips Respironics BiPAP A30 Ventilators may experience interruption or loss of therapy during a Ventilator Inoperative alarm, potentially causing severe respiratory compromise or death in vulnerable patients.

    Product
    BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1262-2024·2024-05-29

    Fresh soft white cheese recalled for potential Listeria contamination

    Tama Corporation is recalling Queso de mano (fresh soft white cheese) due to potential Listeria monocytogenes contamination. The affected product was distributed in Utah.

    Product
    Queso de mano, Fresh soft white cheese, NET WT 24 oz.(640g), Keep Refrigerated, plastic container, packed 12 plastic containers of 24 oz per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1813-2024·2024-05-29

    BiPAP A40 ventilators risk therapy loss during alarm condition

    BiPAP A40 ventilators may lose therapy delivery during a Ventilator Inoperative alarm, potentially causing respiratory failure or death in vulnerable patients.

    Product
    BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1247-2024·2024-05-29

    Sammy's Milk Goat Formula Recalled for Misleading Infant Safety Claims

    Sammy's Milk goat formula is recalled for marketing it as safe for infants. The unapproved product does not comply with FDA infant formula manufacturing requirements.

    Product
    Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch
    Category
    Food
    Distribution
    43 states
  • SevereFDA (Food)·F-1252-2024·2024-05-29

    Geissler's Supermarket Pink Lady Salmon Roll Recalled for Undeclared Egg Allergen

    Geissler's Supermarket is recalling Pink Lady Salmon & Avo Roll Combo sushi due to undeclared egg allergen. Consumers with egg allergies risk allergic reactions if they consume this product.

    Product
    Geissler's Supermarket Pink Lady Salmon &Avo Roll Combo (sushi roll) Ingredients read in part: "***INGREDIENTS: SALMON, AVOCADO, WATER. NORI.WHITESTEAMEORICE. VINEGAR. SUGAR. SALT.LEMON.MIRIN. WASABI. GINGER. SOYSAUCE (WHEAT, SOYBEANS,ALCOHOL) HOT SAUCE: SUGAR. MAYO. CHILI, SRIR
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1811-2024·2024-05-29

    Optum Nimbus II Plus Infusion Pump Recall Due to Potential Failure Modes

    OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.

    Product
    Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1255-2024·2024-05-29

    Geissler's Supermarket Spicy Tuna Sushi Recalled for Undeclared Egg Allergen

    Geissler's Supermarket is recalling 193 units of Spicy Tuna sushi due to undeclared egg allergen. Products distributed in Connecticut and Massachusetts carry best-by dates of March 27 or 28, 2024.

    Product
    Geissler's Supermarket Spicy Tuna (8) Ingredients read in part: "***INGREDIENTS: RICE, NORI, AVOCADO, TUNA, MAYONNAISE, CHILI, SUGAR, SALT, GARLIC, ACETIC ACID, POTASSIUM SORBATE, SODIUM Bl SULATE, XANTHAN GUM, VINEGAR, ORANGE JUICE, ALCOHOL, HIGH FRUCTOSE CORN SYRUP, WATER, CIT
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1254-2024·2024-05-29

    Geissler's Supermarket Spicy Salmon Sushi Recalled for Undeclared Egg Allergen

    Geissler's Supermarket is recalling Spicy Salmon sushi because the product contains egg in mayonnaise but does not declare this allergen on the label. This poses a serious risk to people with egg allergies.

    Product
    Geissler's Supermarket Spicy Salmon 9.6 oz Ingredients read in part: "***INGREDIENTS:RICE, NORI, AVOCADO, SALMON, MAYONNAISE, CHILI, SUGAR, SALT, GARLIC, ACETIC ACID, POTASSIUM SORBATE, SODIUM Bl SULFITE, XANTHAN GUM, VINEGAR, ORANGE JUICE, ALCOHOL, HIGH FRUCTOSE CORN SYRUP, WAT
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1248-2024·2024-05-29

    Sammy's Milk Goat Formula Recalled for Misleading Infant Safety Claims

    Sammy's Milk Goat Milk Toddler Formula is recalled because the manufacturer made false claims it was safe for infants as a sole nutrition source. The product lacks FDA premarket approval and does not meet infant formula manufacturing standards.

    Product
    Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak
    Category
    Food
    Distribution
    43 states
  • SevereFDA (Food)·F-1253-2024·2024-05-29

    Geissler's Supermarket Shrimp Tempura Recalled for Undeclared Wheat

    Geissler's Supermarket is recalling Shrimp Tempura and Spicy Shrimp sushi rolls due to wheat in the tempura batter that is not declared on the label. Consumers with wheat allergies risk allergic reaction.

    Product
    Geissler's Supermarket Shrimp Tempura and Spicy Shrimp Ingredients read in part: "***INGREDIENTS:RICE, NORI, AVOCADO, CUCUMBER,SHRIMP TEMPURA,SHRIMP, CAYENNE PEPPER PUREE, RED JALAPENO PEPPERS, ORGANIC DRIED GARLIC, CAYENNE POWDER, XANTHAN GUM, CITRIC ACID, SOY PROTEIN, VINEGAR
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1662-2024·2024-05-22

    Cardiac Catheters Recalled for Material Delamination Risk

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters worldwide due to polyurethane delamination and material detachment that prevents guidewire advancement.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1680-2024·2024-05-22

    Expo 5F Selective Angiographic Catheters Recalled for Material Delamination

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1659-2024·2024-05-22

    Expo selective angiographic cardiac catheters recalled for guidewire advancement failure

    Boston Scientific is recalling Expo 5F selective angiographic catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1647-2024·2024-05-22

    Angiographic Catheters Recalled for Polyurethane Delamination and Malfunction

    Boston Scientific recalls Expo 5F angiographic catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The recall affects 3,127 units in specific batches distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1652-2024·2024-05-22

    Cardiac Catheters Recalled Due to Delamination and Device Malfunction

    Boston Scientific is recalling 8,725 Expo 5F Selective Angiographic Catheters worldwide due to polyurethane layer delamination and material detachment that prevents guidewire advancement.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1679-2024·2024-05-22

    Boston Scientific Expo 5F Catheters recalled due to material delamination defect

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1675-2024·2024-05-22

    FDA Recalls Boston Scientific Expo 5F Cardiac Catheters Due to Delamination

    Boston Scientific is recalling 8,575 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that prevents guidewire advancement. The FDA Class I recall affects devices distributed worldwide.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1239-2024·2024-05-22

    Garden Veggie Straws recalled due to undeclared milk allergen

    Sensible Portions Garden Veggie Straws Sea Salt contain undeclared milk and pose an allergy risk. The FDA Class I recall affects 2,592 cases distributed across nine states.

    Product
    Sensible Portions brand Garden Veggie Straws Sea Salt. 1 oz bag UPC:2951530057 Packaged in a 30 CT Variety Pack that contains Sea Salt, Cheddar Cheese, and Zesty Ranch in plastic bags. (15 sea salt, 10 ranch, 5 cheddar cheese) UPC: 29515-32543
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1670-2024·2024-05-22

    Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination Risk

    Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in the inner lining. The defect prevents guidewire advancement through the catheter, compromising its function during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states