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.

1951–1975 of 4878

  • SevereFDA (Devices)·Z-2139-2023·2023-08-02

    HAMILTON C1 Ventilator Recalled for Software Defect Causing Unexpected Shutdown

    Hamilton Medical is recalling 689 HAMILTON C1 Ventilators due to a software defect that causes unexpected shutdown after approximately 91 days of use. The device may enter ambient mode without notice, interrupting ventilatory support.

    Product
    HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2141-2023·2023-08-02

    Hamilton C2 Ventilator recalled for software anomaly causing loss of function

    FDA is recalling 399 Hamilton C2 Ventilators due to a software anomaly that may cause the device to stop unexpectedly after approximately 91 days of use. Affected facilities should verify serial numbers and contact the manufacturer.

    Product
    HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2142-2023·2023-08-02

    Hamilton C3 ventilator software anomaly may cause unexpected device stoppage

    A software anomaly in the Hamilton C3 Ventilator may cause it to unexpectedly stop and enter ambient mode without warning after approximately 91 days of use. Approximately 701 systems are affected.

    Product
    HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2140-2023·2023-08-02

    HAMILTON T1 Ventilator software defect may cause unexpected shutdown

    Hamilton Medical is recalling 2,319 HAMILTON T1 Ventilators due to a software anomaly that may cause the device to stop and enter ambient mode after approximately 91 days of use.

    Product
    HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2150-2023·2023-07-26

    Intra-Aortic Balloon Pump may fail to charge batteries, interrupting therapy

    The Cardiosave Rescue Intra-Aortic Balloon Pump may lose battery charging ability in one or both bays, potentially interrupting therapy if disconnected from power. Low battery alarms may alert users before therapy stops.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1272-2023·2023-07-26

    Frozen fruit medley recalled due to potential Listeria contamination

    Townsend Farms is recalling Private Selection 48oz Classic Fruit Medley due to potential contamination with Listeria monocytogenes. The frozen product was distributed across 16 states.

    Product
    Private Selection 48oz Classic Fruit Medley, frozen product, 8/48 oz bags per case. UPC 0 11110 82026 6. Distributed by The Kroger Co. Cincinnati, OH
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2152-2023·2023-07-26

    Cardiosave Rescue IABP Recalled Due to Unexpected Shutdown Risk

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to capacitor failures that may cause unexpected device shutdown. The devices may stop delivering therapy without warning.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2115-2023·2023-07-26

    Impella CP Blood Pump Recalled for Blade Destruction From Stent Interaction

    Abiomed's Impella CP cardiac pump can be damaged by interaction with replacement heart valves, potentially causing blood clots. The FDA classified this as a Class I recall of 9,252 units worldwide.

    Product
    Impella CP intravascular micro axial blood pump, Product Number 0048-0032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1255-2023·2023-07-26

    Frozen Pineapple Products Recalled Due to Listeria Contamination

    Scenic Fruit Company recalls Cadia and Trader Joe's frozen pineapple products due to potential Listeria monocytogenes contamination. Consumers should not consume the recalled items.

    Product
    Cadia - Organic Pineapple Frozen Fruit, packaged in stand-up pouch, net wt. 10oz. Each case consists of 12 bags. Product of Mexico. UPC on Retail Bag: 815369014540 UPC on Case: 10815369014547 Cadia FS - Organic Frozen Pineapple Chunks, net wt. 5lbs. Each case consists of 4
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1256-2023·2023-07-26

    Frozen Pineapple Chunks Recalled Due to Listeria Contamination Risk

    SunOpta Grains and Foods Inc. is recalling nationwide frozen pineapple chunks sold under the 365 Whole Foods Market and Bulk Organic brands due to potential Listeria monocytogenes contamination.

    Product
    Pineapple Chunks packaged under the following brand names and sizes. 1. 365 Whole Foods Market, Net Wt 16 oz (1 lb) 454g UPC 0 99482-40854 1. Keep Frozen. Distributed by: Whole Foods Market, Austin, TX 78703. 2. 365 Whole Foods Market, Net Wt 10 oz (284g) UPC 0 994
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1273-2023·2023-07-26

    Frozen Tropical Mango Chunks Recalled for Listeria Risk

    Townsend Farms Inc is recalling Private Selection frozen tropical mango chunks due to potential Listeria monocytogenes contamination. The product was distributed across 16 U.S. states.

    Product
    Private Selection 48oz Tropical Mango Chunks, frozen product, 8/48 oz bags per case. UPC 0 11110 84663 1. Distributed by The Kroger Co. Cincinnati, OH
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1258-2023·2023-07-26

    365 Whole Foods Market Organic Strawberries Recalled for Potential Listeria Contamination

    SunOpta Grains and Foods Inc. is recalling 365 Whole Foods Market Organic Whole Strawberries due to potential Listeria monocytogenes contamination. The frozen strawberries were distributed nationwide.

    Product
    365 Whole Foods Market Organic Whole Strawberries. Net Wt 32 oz (2 lb) 907 g, UPC 0 99482-45713 6. Keep Frozen until ready to use. Distributed By: Whole Foods Market, Austin, TX 78703
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1271-2023·2023-07-26

    Seasons Choice Mixed Fruit Recalled for Potential Listeria Contamination

    Aldi's Seasons Choice Mixed Fruit is being recalled nationwide due to potential contamination with Listeria monocytogenes. Affected lot codes are FMX227603, FMX227604, and FMX227605.

    Product
    Seasons Choice Mixed Fruit, Strawberries, Pinneapple, Peaches & Mango, Net Wt 32 oz (2lb) 907g. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2017-2023·2023-07-26

    Olympus EVIS EXERA III Bronchovideoscope Combustion Hazard Recall

    Olympus is recalling EVIS EXERA III Bronchovideoscopes nationwide due to complaints of endobronchial combustion during therapeutic laser procedures. This FDA Class I recall affects approximately 9,684 units.

    Product
    Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1266-2023·2023-07-26

    Good & Gather Mango Strawberry Blend recalled for Listeria contamination risk

    Target's Good & Gather Mango Strawberry Blend is being recalled nationwide due to potential Listeria monocytogenes contamination. Listeria can cause serious illness.

    Product
    Good & Gather Mango Strawberry Blend. Whole Strawberries, Mango chunks & Pineapple Chunks. Net Wt 48 oz (3lb) 1.36kg, UPC 0 85239-04803 0. Keep Frozen. Dist. By Target Corp, Minneapolis, MN 55403
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2112-2023·2023-07-26

    Impella 5.0 Blood Pump Recalled for Potential Impeller Blade Destruction Risk

    Abiomed's Impella 5.0 intravascular blood pump is recalled due to risk of impeller blade destruction when interacting with heart valve replacements. The damaged pump can cause reduced blood flow and potentially release fractured material into the bloodstream.

    Product
    Impella 5.0 intravascular micro axial blood pump, Product Number 005062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2114-2023·2023-07-26

    Abiomed Impella 5.5 pump recalled due to impeller blade damage risk

    Abiomed is recalling the Impella 5.5 with SmartAssist pump due to a risk of impeller blade destruction when used with aortic valve replacement devices. Damage can result in low blood flow and systemic embolization, where broken pump pieces may enter the bloodstream.

    Product
    Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1293-2023·2023-07-26

    Organic Asian Chopped Salad Kits Recalled for Undeclared Milk and Egg

    Braga Fresh Foods is recalling 673 cases of 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kits due to undeclared milk and egg allergens. Consumers with allergies to these allergens should not consume these products.

    Product
    365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kits 12 oz plastic bags 9 bags per case UPC: 9948246932 Item#: 9770522
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1269-2023·2023-07-26

    Frozen Mixed Fruit Blend Recalled for Potential Listeria Contamination

    SunOpta's Good & Gather brand frozen mixed fruit blend is recalled nationwide due to potential Listeria monocytogenes contamination. Affected consumers should not consume this product and should return it to the retailer.

    Product
    Good & Gather Mixed Fruit Blend Pineapple Chunks, Sliced Strawberries, Mango Chunks & Sliced Peaches. Net Wt 48 oz (3lb) 1.36kg. UPC 0 85239-04821 4. Keep Frozen. Dist. By Target Corp, Minneapolis, MN 55403
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2151-2023·2023-07-26

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalls due to unexpected device shutdown

    Datascope has recalled Cardiosave Hybrid IABP models due to tantalum capacitor failures that may cause unexpected device shutdown, interrupting life-critical cardiac therapy.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2149-2023·2023-07-26

    Cardiosave Hybrid IABP may fail to charge batteries, interrupting therapy

    The Cardiosave Hybrid Intra-Aortic Balloon Pump may lose the ability to charge batteries in one or both bay slots, potentially interrupting critical therapy if disconnected from AC power. Low battery alarms may alert users before therapy is interrupted.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2116-2023·2023-07-26

    Impella CP cardiac pump recalls due to motor housing interaction with stents

    Abiomed is recalling Impella CP with SmartAssist blood pumps due to risk of motor housing interaction with transcatheter aortic valve replacement devices, which can damage the pump's impeller blades and reduce blood flow.

    Product
    Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1260-2023·2023-07-26

    365 Whole Foods Organic Blackberries Recalled for Potential Listeria Monocytogenes

    Whole Foods Market is recalling 365 brand organic blackberries due to potential Listeria monocytogenes contamination. The frozen fruit was distributed nationwide.

    Product
    365 Whole Foods Market Organic Blackberries. Net Wt 10 oz (284g), UPC 0 99482-40605 9. Keep Frozen. Distributed by: Whole Foods Market, Austin, TX 78703
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1264-2023·2023-07-26

    Whole Foods Organic Sliced Strawberries and Bananas Recalled for Listeria Risk

    SunOpta Grains and Foods Inc. is recalling 365 Whole Foods Market Organic Sliced Strawberries & Bananas due to potential Listeria monocytogenes contamination. The frozen fruit products were distributed nationwide.

    Product
    365 Whole Foods Market Organic Sliced Strawberries & Bananas. Net Wt 32 oz (2 lb) 907g, UPC 0 99482-51908 7, Keep Frozen until ready to use. Distributed By: Whole Foods Market, Austin, TX 78703
    Category
    Food
    Distribution
    Distributed nationwide