The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

18801–18825 of 88183

  • CriticalFDA (Food)·F-0885-2023·2023-05-24

    Highkey Soft Baked Mini Treats recalled for undeclared egg allergen

    Highkey Soft Baked Mini Treats Birthday Cake was recalled because egg allergen was not listed on the label, causing an allergic reaction in a consumer. The product was distributed to seven U.S. states.

    Product
    Highkey Soft Baked MINI TREATS BIRTHDAY CAKE NET WT 2 OZ (57g) CONTAINS: ALMONDS, MILD, AND COCONUT. DISTRIBUTED BY SUMMIT NATURALS INC ORLANDO, FL 32826 UPC 8 50020 43374 2
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Devices)·Z-1447-2023·2023-05-24

    Draeger VentStar Anesthesia Breathing Circuit Connections May Detach

    Draeger Medical recalls VentStar Anesthesia (N) 180 breathing circuits. Glued connections can loosen or detach during ventilation, potentially creating a critical disconnection risk.

    Product
    VentStar Anesthesia (N) 180, MP00333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0893-2023·2023-05-24

    SW Texas Nut Blend Recalled for Undeclared Almonds and Cashews

    SW Texas Nut Blend (Item #5180819) is being recalled due to undeclared almonds and cashews. The product label lists only hazelnuts and walnuts as ingredients.

    Product
    SW Texas Nut Blend, Item #5180819, Packed in cardboard box with poly liner; net wt. 25 lbs. No UPC. Label declares: SW Texas Nut Blend, ingredients: Hazelnuts, Walnuts. Manufactured by: Ardent Mills Ave. Tualatin, OR.
    Category
    Food
    Distribution
    1 state
  • 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 (Devices)·Z-1460-2023·2023-05-24

    Anesthesia circuit kit may detach during ventilation due to loose glued connections

    Draeger Medical is recalling its Anesthesia Circuit Kit Coax HEPA (720 units) because glued connections can become loose during ventilation, potentially causing partial or complete detachment that could interrupt oxygen delivery during surgery.

    Product
    Anesthesia Circuit Kit Coax HEPA, MP17102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1458-2023·2023-05-24

    Anesthesia Set Coax 180 Breathing Circuit Connection Risk

    Draeger Medical is recalling the Anesthesia Set Coax 180 because glued breathing circuit connections can become loose during ventilation, causing partial or complete detachment.

    Product
    Anesthesia Set Coax 180, MP03384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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 (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-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-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-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 (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 (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