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.

9401–9425 of 29156

  • SevereFDA (Devices)·Z-2611-2020·2020-07-22

    Medtronic Bone Void Filler Recalled for Potential Failure to Set Properly

    Skeletal Kinetics is recalling Medtronic Bone Void Filler kits that may not maintain setting characteristics, potentially increasing surgical time or causing bone formation issues.

    Product
    MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-1133-2020·2020-07-22

    Fresh Express Marketside Shredded Iceberg Lettuce Recalled for Cyclospora Risk

    Fresh Express is recalling Marketside Shredded Iceberg Lettuce due to a possible health risk from Cyclospora. Consumers should check their refrigerators for affected products.

    Product
    Marketside Shredded Iceberg Lettuce 8 oz., UPC 681131328968, Iceberg lettuce
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1141-2020·2020-07-22

    Fresh Express Organic Sesame Asian Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Wholesome Pantry Organic Sesame Asian Salad Kits due to a possible health risk from Cyclospora. Consumers should not eat the product.

    Product
    Wholesome Pantry Organic Sesame Asian Salad Kit 13 oz., UPC 041190066292, Organic green cabbage, organic romaine Lettuce, organic radicchio, organic carrots & organic green onions
    Category
    Food
    Distribution
    32 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 (Drugs)·D-1386-2020·2020-07-22

    Granules Pharmaceuticals Recalls Metformin Hydrochloride Extended-Release Tablets

    Granules Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets due to FDA detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    METFORMIN — METFORMIN (METFORMIN ER 500 MG)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-1135-2020·2020-07-22

    Fresh Express Signature Farms Coleslaw Recalled for Cyclospora Risk

    Fresh Express is recalling Signature Farms Coleslaw 3 Color 14 oz. due to a possible health risk from Cyclospora.

    Product
    Signature Farms Coleslaw 3 Color 14 oz., UPC 021130111691, Green & red cabbage and carrots
    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-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 (Food)·F-1118-2020·2020-07-22

    Fresh Express Marketside Asian Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Marketside Chopped Salad Kit Asian products due to a possible health risk from Cyclospora. Consumers should check their refrigerators for affected items.

    Product
    Marketside Chopped Salad Kit Asian 13.7 oz., UPC 681131007047, Green & red cabbage, kale, romaine lettuce & carrots
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1071-2020·2020-07-22

    Fresh Express Iceberg Garden Salads 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 12 oz., UPC 071279103020, (Canada UPC) 0 71279 10302 0, Green and red cabbage, kale, green leaf & Carrots. Fresh Express Iceberg Garden / Lechuga Repollo 24 oz., UPC 071279104119, (Canada UPC) 0 71279 10411 9, Iceberg lettuce, ca
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2613-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation EX Bone Void Filler Kits

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

    Product
    OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - 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 c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1053-2020·2020-07-22

    Fresh Express Cole Slaw Recalled Due to Cyclospora Risk

    Fresh Express America's Fresh Old Fashioned Cole Slaw is recalled due to a possible health risk from Cyclospora. Consumers should check for specific product codes and dates.

    Product
    Fresh Express America's Fresh Old Fashioned Cole Slaw" 14oz, UPC 071279123011, Green cabbage & carrots
    Category
    Food
    Distribution
    32 states
  • 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 (Drugs)·D-1384-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Extended-Release 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 (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 (Devices)·Z-2585-2020·2020-07-22

    CME America Recalls Infusion Sets Due to Delivery Inaccuracy

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

    Product
    Standard BodySet with Needleless Connectors, REF: A120-125XS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2579-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America is recalling 4,234 CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.

    Product
    CMExpress Microbore Sets, REF: A120-160C2YRV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2631-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD RENU FLOW Bone Void Filler Kits

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

    Product
    SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - 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
    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
  • SevereFDA (Devices)·Z-2586-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America is recalling 13,280 CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.

    Product
    CMExpress Microbore Set, REF: A120-160C
    Category
    Medical Device
    Distribution
    49 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