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.

9426–9450 of 29156

  • SevereFDA (Devices)·Z-2557-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Administration Sets

    CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that could cause over- or under-infusion of therapy.

    Product
    BodyGuard Microset, REF: A120-161XPS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Food)·F-1126-2020·2020-07-22

    Fresh Express Marketside Classic Iceberg Salad Recalled for Cyclospora Risk

    Fresh Express is recalling Marketside Classic Iceberg Salad due to a possible health risk from Cyclospora. Consumers should not eat the product.

    Product
    Marketside Classic Iceberg Salad 24 oz., UPC 681131328951, Red cabbage, iceberg lettuce & carrots
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2587-2020·2020-07-22

    CME America Recalls CMExpress Needleless Y Site Microbore Sets

    CME America is recalling 1,824 CMExpress Needleless Y Site Microbore Sets due to delivery inaccuracy that could cause over- or under-infusion of therapy.

    Product
    CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2563-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Administration Sets

    CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that could cause over-infusion or under-infusion of therapy.

    Product
    BodyGuard Microset, REF: A120-161XYBS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2588-2020·2020-07-22

    CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over- or under-infusion.

    Product
    BodyGuard Microset With Female Luer, REF: A120-160XPSN
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Food)·F-1140-2020·2020-07-22

    Fresh Express Organic Chopped Sesame Asian Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Wholesome Pantry Organic Chopped Sesame Asian Salad Kits due to a possible health risk from Cyclospora. Consumers should check their refrigerators for the affected product.

    Product
    Wholesome Pantry Organic Chopped Sesame Asian Salad Kit 10.9 oz., UPC 041190066308, Organic green cabbage, organic romaine Lettuce, organic radicchio, organic carrots & organic green onions
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1076-2020·2020-07-22

    Fresh Express Premium Slaw Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Premium Slaw Salad Kit Asian Avocado products due to a possible health risk from Cyclospora.

    Product
    Fresh Express Premium Slaw Salad Kit Asian Avocado 9.7 oz., UPC 071279126043, Romaine lettuce & red cabbage
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1099-2020·2020-07-22

    Fresh Express Recalls Hy-Vee Asian Salad Kits Due to Cyclospora Risk

    Fresh Express is recalling Hy-Vee Chopped Kit Asian Salad products due to a possible health risk from Cyclospora. Consumers should not consume the affected items.

    Product
    Hy-Vee Chopped Kit Asian Salad 13.7 oz., UPC 075450246681, Red & green cabbage, gree leaf lettuce, carrots & greens onions
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1068-2020·2020-07-22

    Fresh Express Turkey and Bacon Chef Salad Recalled for Cyclospora Risk

    Fresh Express is recalling specific Turkey & Bacon Chef salads due to a possible health risk from Cyclospora. Consumers should check use-by dates and discard affected products.

    Product
    Fresh Express Gourmet Cafe Creative Classics Turkey & Bacon Chef 5.75 oz.,UPC 071279407081, Iceberg & romaine lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1128-2020·2020-07-22

    Fresh Express Marketside Crisp Greens Recalled Due to Cyclospora Risk

    Fresh Express is recalling Marketside Crisp Greens 12 oz. due to a possible health risk from Cyclospora. Consumers should not consume the product.

    Product
    Marketside Crisp Greens 12 oz., UPC 681131387552, Romaine lettuce, red cabbage, iceberg lettuce & carrots
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Drugs)·D-1385-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2565-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with significant inaccuracy, potentially causing over-infusion or under-infusion.

    Product
    BodyGuard Microset, REF: A120-161XPSV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Food)·F-1062-2020·2020-07-22

    Fresh Express Thai 'N' Cashews Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Thai 'N' Cashews salad kits due to a possible health risk from Cyclospora. Consumers should check their refrigerators for affected products.

    Product
    Fresh Express Chopped Kit Thai 'N' Cashews 11.7 oz, UPC 071279309248, (Canada UPC) 0 71279 30925 5, Green and red cabbage, green leaf lettuce, carrots & green onions
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2572-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.

    Product
    BodyGuard Microset with Filter, REF: A100-164XESF
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Drugs)·D-1382-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2596-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Impact Bone Void Filler Kits

    Skeletal Kinetics is recalling 41 units of Acumed Impact 5CC bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2570-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America, LLC is recalling BodyGuard Microset infusion administration sets because they may deliver fluids with an inaccuracy exceeding plus/minus 13%, risking over- or under-infusion of therapy.

    Product
    BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Food)·F-1094-2020·2020-07-22

    Fresh Express Romaine Garden Salad Blend Recalled for Cyclospora Risk

    Fresh Express is recalling Giant Eagle Romaine Garden Salad Blend due to a possible health risk from Cyclospora. The product was distributed in 33 US states and Canada.

    Product
    Giant Eagle Life s Getting Fresher Fresh Romaine Garden Salad Blend 12 oz., UPC 030034923167,Romaine lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1072-2020·2020-07-22

    Fresh Express Iceberg Garden Salad Recalled for Cyclospora Risk

    Fresh Express is recalling Iceberg Garden salad products due to a possible health risk from Cyclospora. Consumers should check their refrigerators for affected lots.

    Product
    Fresh Express Iceberg Garden / Lechuga Repollo 3 lbs., UPC 071279104119, Iceberg lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1115-2020·2020-07-22

    Fresh Express Little Salad Bar Southwest Chopped Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Little Salad Bar Southwest Chopped Salad Kits due to a possible health risk from Cyclospora. Consumers should check their refrigerators for affected products.

    Product
    Little Salad Bar Southwest Chopped Salad Kit 12 oz., UPC 4099100087024, Green and red cabbage, green leaf lettuce, carrots & green onion
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1080-2020·2020-07-22

    Fresh Express Shredded Iceberg Lettuce Recalled for Cyclospora Risk

    Fresh Express is recalling 8 oz. shredded iceberg lettuce due to a possible health risk from Cyclospora. The product was distributed in 33 U.S. states and Canada.

    Product
    Fresh Express SHREDS 8 oz., UPC 071279151014, (Canada UPC) 0 71279 15101 4, Shredded iceberg lettuce
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2632-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects cr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2584-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion sets because they may deliver fluid at inaccurate rates, potentially causing over- or under-infusion of therapy.

    Product
    BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
    Category
    Medical Device
    Distribution
    49 states