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.

2451–2475 of 4878

  • SevereFDA (Food)·F-0921-2023·2023-05-31

    Multiple kale greens products recalled for possible Listeria contamination

    Lancaster Foods LLC is recalling ROBINSON FRESH and LANCASTER kale greens products due to possible Listeria monocytogenes contamination. Affected products have a best-by date of May 1, 2023, and were distributed in MA, MD, PA, NY, NJ, and VA.

    Product
    ROBINSON FRESH KALE GREENS, NET WT 16 OZ, UPC:0-95829-60015. Packaged in sealed plastic bags, 8 in a case. ROBINSON FRESH KALE GREENS NET WT 32 OZ UPC: 0-95829-60016-6. Packaged in sealed plastic bags, 8 in a case. LANCASTER Chopped Kale NET WT 4 OZ CHOPPED KALE. Packaged in
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0890-2023·2023-05-24

    Ground Cumin Distributed by Lipari Foods Recalled for Salmonella

    Lipari Foods is recalling 147 cases of ground cumin contaminated with Salmonella. The product was distributed to retail stores across 16 states.

    Product
    Distributed by Lipari Foods Ground Cumin in 6oz plastic tub, UPC 094776212620, 12 retail units per wholesale case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1455-2023·2023-05-24

    Ventstar Coax 180 Ventilator Breathing Circuit Connections May Detach

    Draeger Medical is recalling 18,160 Ventstar Coax 180 ventilators because glued breathing circuit connections can become loose and detach during use, potentially disrupting oxygen delivery.

    Product
    Ventstar Coax 180, MP03374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1566-2023·2023-05-24

    Plum A+ & A+3 Infusion System Batteries Recalled Due to Manufacturing Defect

    ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.

    Product
    Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0892-2023·2023-05-24

    Oregon Nut Blend Recalled for Undeclared Almonds and Cashews

    Willamette Hazelnut, Inc. is recalling Oregon Nut Blend because it contains undeclared almonds and cashews. This poses a risk to consumers allergic to these nuts.

    Product
    Oregon Nut Blend, Item # 5180808, Packed in cardboard box with poly liner; net wt. 25 lbs. No UPC. Label declares: Oregon Nut Blend, Innovative Bakery Resources. Ingredients: Hazelnuts, Walnuts. Product of USA. Manufactured By: Ardent Mills Tualatin, OR.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1568-2023·2023-05-24

    ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss

    ICU Medical is recalling ASM Replacement Batteries due to a manufacturing defect from the battery supplier. Affected batteries may lose capacity and runtime earlier than expected during their lifecycle.

    Product
    ASM Replacement Battery, Component Number SUB0000594
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1457-2023·2023-05-24

    Ventstar Coax 230 breathing circuit connections can detach during ventilation

    The FDA is recalling Draeger Medical's Ventstar Coax 230 breathing circuit components due to glued connections that can become loose and detach during ventilation, potentially compromising patient breathing support.

    Product
    Ventstar Coax 230, MP03376
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1451-2023·2023-05-24

    VentStar Coax breathing circuit connections recalled for detachment risk

    Draeger Medical is recalling VentStar Coax (P) 150 breathing circuit components due to potentially loose glued connections that could detach during ventilation, affecting 280 units distributed nationwide.

    Product
    VentStar Coax (P) 150, MP00379
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1440-2023·2023-05-24

    Draeger VentStar Basic ventilator breathing circuit connections may detach during use

    Draeger Medical is recalling 325 VentStar Basic (P)180 ventilators because glued breathing circuit connections can become loose before or during ventilation, potentially causing partial or complete detachment of circuit pieces.

    Product
    VentStar Basic (P)180, MP00351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2023·2023-05-24

    VentStar Basic Ventilator Recall: Risk of Breathing Circuit Detachment

    Draeger Medical is recalling 1,725 VentStar Basic ventilators because glued breathing circuit connections can become loose and detach before or during ventilation. This may disrupt patient breathing support.

    Product
    VentStar Basic (N) 180, MP00353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1565-2023·2023-05-24

    Replacement Battery in Plum 360 Infusion System Recalled for Capacity Loss

    ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.

    Product
    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0919-2023·2023-05-24

    Gold Medal Unbleached All Purpose Flour Recalled for Potential Salmonella Contamination

    General Mills is recalling Gold Medal Unbleached All Purpose Flour for potential Salmonella contamination. The recall affects 142,408 bags distributed nationwide with best-by dates of March 27–28, 2024.

    Product
    Gold Medal Unbleached All Purpose Flour, Enriched, Presifted, packaged in the following sizes: 1. Net Wt 5 lb (2.26kg), UPC 0 16000-19610 0; and 2. Net Wt 10 lb (4.53kg), UPC 0 16000-19580 6. Dist. By General Mills Sales, Inc., Minneapolid, MN 55440.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1445-2023·2023-05-24

    VentStar Breathing Bag Set Recalled for Loose Circuit Connections

    Draeger Medical is recalling VentStar breathing bag sets nationwide due to loose glued connections in the breathing circuit. Connections can detach before or during ventilation.

    Product
    VentStar breathing bag Set (P) 110, MP00384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1590-2023·2023-05-24

    Impella 5.5 with SmartAssist Catheter Recalled for Heightened Purge Leak Rate

    Abiomed is recalling 610 units of the Impella 5.5 with SmartAssist catheter due to a heightened complaint rate for purge leaks. This intravascular pump provides circulatory support during critical care.

    Product
    Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0954-2023·2023-05-24

    Tahini Recall: Salmonella Contamination Risk in Mighty Sesame Organic Product

    Kenover Marketing Corp. is recalling Mighty Sesame Organic Tahini due to potential Salmonella contamination. The affected product was distributed to multiple states.

    Product
    Mighty Sesame 10.9 Oz Organic Tahini (Squeezable) bottle, UPC 858313006208, 8 Units per case.
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Devices)·Z-1442-2023·2023-05-24

    VentStar Watertrap Breathing Circuit Connections May Detach During Use

    Draeger Medical recalls VentStar Watertrap (P) 180 breathing circuit equipment because glued connections can become loose or detach before or during ventilation.

    Product
    VentStar Watertrap (P) 180, MP00361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0884-2023·2023-05-24

    Highkey Banana Nut Muffin Mini Treats Recalled for Undeclared Egg Allergen

    Highkey soft baked MINI TREATS BANANA NUT MUFFIN are being recalled due to undeclared egg on the label. A consumer experienced an allergic reaction to the product.

    Product
    Highkey soft baked MINI TREATS BANANA NUT MUFFIN NET WT 2 OZ (57g) CONTAINS: ALMONDS, MILK, AND PECANS. DISTRIBUTED BY SUMMIT NATURALS INC ORLANDO, FL 32826 UPC 8 50020 43373 5
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1450-2023·2023-05-24

    Draeger VentStar Breathing Circuit Connections May Loosen During Use

    Draeger Medical is recalling the VentStar Bag Set because glued connections on the breathing circuit can become loose or detach during ventilation, potentially compromising respiratory support.

    Product
    VentStar Bag Set (N) 110, MP00383
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1567-2023·2023-05-24

    ASM Replacement Battery Recalled for Manufacturing Defect and Capacity Loss

    ICU Medical is recalling the ASM Replacement Battery due to a manufacturing defect from the battery supplier. The defect may cause batteries to lose capacity and experience decreased runtime earlier than expected.

    Product
    ASM Replacement Battery, Component Number SUB0000864
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1446-2023·2023-05-24

    ID Circuit Basic breathing circuit recalled for loose glued connections

    Draeger Medical is recalling ID Circuit Basic breathing circuits due to glued connections that can loosen during ventilation, potentially causing partial or complete detachment of circuit pieces.

    Product
    ID Circuit Basic (P) 180, MP01340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1449-2023·2023-05-24

    VentStar Watertrap breathing circuit connections may detach during ventilation

    Draeger Medical is recalling the VentStar Watertrap (N) 180 due to glued breathing circuit connections that may become loose or detach during ventilation, posing patient safety risk.

    Product
    VentStar Watertrap (N) 180, MP00363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1444-2023·2023-05-24

    Anesthesia Ventilator Breathing Circuit Connections May Detach During Use

    Draeger Medical is recalling 130 units of the VentStar Anesthesia WT ventilator due to a defect where glued breathing circuit connections may loosen or detach during ventilation, potentially compromising anesthesia delivery.

    Product
    VentStar Anesthesia WT (P)180, MP00374
    Category
    Medical Device
    Distribution
    Distributed nationwide