The Recall Desk

Archive

July 2020 recalls

590 recalls were announced in July 2020.

What the numbers show

Critical
11
Severe
159
High
329
Moderate
75
Low
16

Of the 590 recalls this month scored against our rubric, 2% are Critical, 27% are Severe.

101–200 of 590

  • CriticalFDA (Devices)·Z-2553-2020·2020-07-22

    CME BodyGuard BodySet Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard BodySet, REF: A120-160SAS
    Category
    Medical Device
    Distribution
    49 states
  • CriticalFDA (Devices)·Z-2567-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

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

    Product
    BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
    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-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 (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
  • SevereNHTSA·20V422000·2020-07-22

    Kia Recalls 2020 Stinger Vehicles for Steering Locking Defect

    Kia is recalling 2020 Stinger vehicles with 2.0L Turbo-GDI engines because a steering component may be defective, potentially causing the steering to lock or become difficult while driving.

    Product
    KIA — KIA STINGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-2568-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

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

    Product
    CMExpress Microbore Set, REF: A120-160CRV
    Category
    Medical Device
    Distribution
    49 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 (Devices)·Z-2580-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America is recalling CMExpress Microbore Sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.

    Product
    CMExpress Microbore Sets, REF: A120-161C
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2560-2020·2020-07-22

    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: A100-163XSFL
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2589-2020·2020-07-22

    CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
    Category
    Medical Device
    Distribution
    49 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 (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 (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 (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 (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-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-1109-2020·2020-07-22

    Fresh Express Recalls Hy-Vee Shredded Lettuce Due to Cyclospora Risk

    Fresh Express is recalling Hy-Vee Shredded Lettuce due to a possible health risk from Cyclospora. The product was distributed in 33 U.S. states and Canada.

    Product
    Hy-Vee Shredded Lettuce 8 oz., UPC 075450120530, Iceberg lettuce
    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 (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 (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-2601-2020·2020-07-22

    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, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - 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 f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (Devices)·Z-2605-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling 125 units of Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - 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-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-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 (Devices)·Z-2562-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Administration Sets

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

    Product
    BodyGuard Microset, REF: A120-161XYB
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Food)·F-1056-2020·2020-07-22

    Fresh Express Chopped Kit Bacon & Bleu Recalled for Cyclospora Risk

    Fresh Express is recalling Chopped Kit Bacon & Bleu salads due to a possible health risk from Cyclospora. Consumers should not eat the product.

    Product
    Fresh Express Chopped Kit Bacon & Bleu 10.9 oz, UPC 071279306063, Red and green cabbage, green leaf lettuce, carrots & green onions
    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-1087-2020·2020-07-22

    Fresh Express Mediterranean Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Giant Eagle Chopped Mediterranean Salad Kits due to a possible health risk from Cyclospora.

    Product
    Giant Eagle Chopped Mediterranean Salad Kit 9.9 oz.,UPC 030034923372, Endive, cauliflower, broccoli, carrots, red cabbage & radicchio
    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-1082-2020·2020-07-22

    Fresh Express Veggie Spring Mix Recalled for Cyclospora Risk

    Fresh Express is recalling Veggie Spring Mix 7 oz. bags due to a possible health risk from Cyclospora contamination.

    Product
    Fresh Express Veggie Spring Mix 7 oz., UPC 071279281049, Baby lettuce, carrots, red cabbage & radishes
    Category
    Food
    Distribution
    32 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-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-2569-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America is recalling CMExpress Microbore Sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.

    Product
    CMExpress Microbore Set, REF: A120-161CYF
    Category
    Medical Device
    Distribution
    49 states
  • 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 (Devices)·Z-2564-2020·2020-07-22

    CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard Microset with Filter, REF: A100-163XESF
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2558-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Administration Sets

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

    Product
    BodyGuard Microset, REF: A120-160XSFK
    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-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 (Devices)·Z-2573-2020·2020-07-22

    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-infusion or under-infusion.

    Product
    BodyGuard Microset, REF: A100-163XE90S
    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-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-2578-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

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

    Product
    CMExpress Microbore Sets, REF: A120-160CYFRV
    Category
    Medical Device
    Distribution
    49 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-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-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-1120-2020·2020-07-22

    Fresh Express Marketside Chopped Salad Kit Recalled for Cyclospora Risk

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

    Product
    Marketside Chopped Salad Kit Cherry Almond Gorgonzola 13.8 oz., UPC 681131148375, Green & red cabbage, kale, romaine lettuce, green onions & carrots
    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-1138-2020·2020-07-22

    Fresh Express Signature Farms Green & Crisp Salad Recalled for Cyclospora Risk

    Fresh Express is recalling Signature Farms Green & Crisp salads due to a possible health risk from Cyclospora. Consumers should check their refrigerators for the affected product.

    Product
    Signature Farms Green & Crisp 11 oz., UPC 021130419128, Iceberg Lettuce, Romaine, red cabbage and carrots
    Category
    Food
    Distribution
    32 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 (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 (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-1065-2020·2020-07-22

    Fresh Express Farmer's Garden Salad Recalled for Cyclospora Risk

    Fresh Express is recalling Farmer's Garden salads due to a possible health risk from Cyclospora. Consumers should check their refrigerators for the affected product.

    Product
    Fresh Express Farmer's Garden 9 oz., UPC 071279281025, Butter & red leaf lettuce, grape tomatoes, carrots & radishes
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2615-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation RMX Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation RMX bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - 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 tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (Drugs)·D-1383-2020·2020-07-22

    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 (Food)·F-1129-2020·2020-07-22

    Fresh Express Marketside Kale Slaw Recalled for Cyclospora Risk

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

    Product
    Marketside Kale Slaw 12 oz., UPC 681131221573, Broccoli stalks, kale, radicchio, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2583-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America is recalling 6,320 BodyGuard Microset infusion sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.

    Product
    BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
    Category
    Medical Device
    Distribution
    49 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
  • HighFDA (Food)·F-1061-2020·2020-07-22

    Fresh Express Chopped Kit Southwest Recalled for Cyclospora Risk

    Fresh Express is recalling Chopped Kit Southwest products due to a possible health risk from Cyclospora.

    Product
    Fresh Express Chopped Kit Southwest 11.5 oz, UPC 071279306025,(Canada UPC) 0 71279 30930 9, Red and green cabbage, green leaf lettuce, carrots & green onions
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2603-2020·2020-07-22

    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, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - 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
  • HighFDA (Devices)·Z-2608-2020·2020-07-22

    Skeletal Kinetics Recalls Ossilix Form Bone Void Filler Kits

    Skeletal Kinetics is recalling 20 units of Ossilix Form bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 813845021037 - 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 cre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2594-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits

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

    Product
    ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - 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 fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1105-2020·2020-07-22

    Fresh Express Garden Salad Recalled for Possible Cyclospora Risk

    Fresh Express is recalling Hy-Vee Garden Salad products due to a possible health risk from Cyclospora. Consumers should check product codes and dates.

    Product
    Hy-Vee Garden Salad 12 oz., UPC 075450246742, Iceberg lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighNHTSA·20V423000·2020-07-22

    Thor Motor Coach Motorhomes Recalled for Electrical System Fire Hazard

    Thor Motor Coach is recalling certain 2019-2021 Freedom Elite and 2021 Four Winds motorhomes due to an incorrect converter breaker installation that can cause wiring to overheat and increase fire risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH FOUR WINDS, FREEDOM ELITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2635-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Due to Setting Defects

    Skeletal Kinetics is recalling 51 units of Craniosculpt bone void filler because the product may not maintain its setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - 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 creat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1091-2020·2020-07-22

    Fresh Express American Blend Salad Recalled Due to Cyclospora Risk

    Fresh Express is recalling Giant Eagle American Blend salads due to a possible health risk from Cyclospora. Consumers should check their refrigerators for affected products.

    Product
    Giant Eagle Life s Getting Fresher Fresh American Blend 11 oz., UPC 030034923105, Iceberg & romaine lettuce, carrots, red cabbage & radish
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1137-2020·2020-07-22

    Fresh Express Signature Farms Lettuce Shreds Recalled for Cyclospora Risk

    Fresh Express is recalling Signature Farms Lettuce Shreds due to a possible health risk from Cyclospora. The product is distributed in 33 US states and Canada.

    Product
    Signature Farms Lettuce Shreds 8 oz., UPC 021130112180, Iceberg Lettuce
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1020-2020·2020-07-22

    HKH JVC LLC Recalls Garlic Shrimp Poke for Listeria Risk

    HKH JVC LLC is recalling Garlic Shrimp Poke in Hawaii due to potential Listeria monocytogenes contamination.

    Product
    Garlic Shrimp Poke weighed and packed in plastic containers in the deli section per customer request. Cooked Shrimp is received in 10 lb. boxes.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1123-2020·2020-07-22

    Fresh Express Marketside Chopped Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Marketside Chopped Salad Kits due to a possible health risk from Cyclospora. Consumers should not consume the affected products.

    Product
    Marketside Chopped Salad Kit Sunflower Bacon Crunch 13.8 oz., UPC 681131148344, Green & red cabbage, kale, romaine lettuce, green onions & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1107-2020·2020-07-22

    Fresh Express Recalls Hy-Vee Italian Salad Mix Due to Cyclospora Risk

    Fresh Express is recalling Hy-Vee Italian Salad Mix 10 oz. due to a possible health risk from Cyclospora. Consumers should check their pantries for affected products.

    Product
    Hy-Vee Italian Salad Mix 10 oz., UPC 075450120486, Romaine lettuce & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1132-2020·2020-07-22

    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 product codes and dates.

    Product
    Marketside Shredded Iceberg Lettuce 16 oz., UPC 681131532099, Iceberg lettuce
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1096-2020·2020-07-22

    Fresh Express Recalls Giant Eagle Veggie Lovers Salad Due to Cyclospora Risk

    Fresh Express is recalling Giant Eagle Veggie Lovers salads due to a possible health risk from Cyclospora. Consumers should not consume the affected products.

    Product
    Giant Eagle Life s Getting Fresher Veggie Lovers 11 oz., UPC 030034923280, Iceberg & romaine lettuce, carrots, pea pods, radishes & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2600-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling 70 units of Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - 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 fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1059-2020·2020-07-22

    Fresh Express Chopped Kit Pomegranate Recalled for Cyclospora Risk

    Fresh Express is recalling Chopped Kit Pomegranate salads due to a possible health risk from Cyclospora. Consumers should check their refrigerators for affected products.

    Product
    Fresh Express Chopped Kit Pomegranate 10.3 oz, UPC 071279309101, Red and green cabbage, kale, green leaf lettuce & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2597-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt C bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - 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 trau
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2636-2020·2020-07-22

    Skeletal Kinetics Recalls Ossilix Bone Void Filler Kits Due to Setting Defects

    Skeletal Kinetics is recalling 60 units of Ossilix MP Fil bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - 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 create
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1116-2020·2020-07-22

    Fresh Express Sunflower Chopped Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Little Salad Bar Sunflower Chopped Salad Kits due to a possible health risk from Cyclospora.

    Product
    Little Salad Bar Sunflower Chopped Salad Kit 11.1 oz., UPC 4099100087901, Green and red cabbage, green leaf lettuce & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1131-2020·2020-07-22

    Fresh Express Marketside Premium Romaine Salad Recalled for Cyclospora Risk

    Fresh Express is recalling Marketside Premium Romaine Salad due to a possible health risk from Cyclospora. The product was distributed in 33 U.S. states and Canada.

    Product
    Marketside Premium Romaine Salad 9 oz., UPC 681131387538, Romaine lettuce, red cabbage & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1066-2020·2020-07-22

    Fresh Express Chopped Asian Salad Recalled for Cyclospora Risk

    Fresh Express Incorporated is recalling specific Chopped Asian salad products due to a possible health risk from Cyclospora.

    Product
    Fresh Express Gourmet Cafe Creative Classics Chopped Asian 6.25 oz., UPC 071279407111, Red and green cabbage, romaine lettuce, carrots & green onions
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1085-2020·2020-07-22

    Fresh Express Recalls Giant Eagle Chopped BBQ Ranch Salad Kits

    Fresh Express is recalling Giant Eagle Chopped BBQ Ranch Salad Kits due to a possible health risk from Cyclospora contamination.

    Product
    Giant Eagle Chopped BBQ Ranch Salad Kit 11.3 oz., UPC 030034923303, Cabbage and lettuce, carrots, and green onion
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2619-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - 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 crea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1058-2020·2020-07-22

    Fresh Express Chopped Kit Chipotle Cheddar Recalled for Cyclospora Risk

    Fresh Express is recalling Chopped Kit Chipotle Cheddar salads due to a possible health risk from Cyclospora contamination.

    Product
    Fresh Express Chopped Kit Chipotle Cheddar 11.4 oz, UPC 071279306049, (Canada UPC) 0 71279 30931 6, Red and green cabbage, green leaf lettuce, carrots & green onions
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1110-2020·2020-07-22

    Fresh Express Recalls Hy-Vee Veggie Deluxe Salad Mix Due to Cyclospora Risk

    Fresh Express is recalling Hy-Vee Veggie Deluxe Salad Mix due to a possible health risk from Cyclospora. Consumers should check for specific product codes and discard the product.

    Product
    Hy-Vee Veggie Deluxe Salad Mix 12 oz., UPC 075450085303, Iceberg lettuce, carrots, romaine lettuce, pea pods, radishes & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1077-2020·2020-07-22

    Fresh Express Premium Slaw Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Premium Slaw Salad Kits due to a possible health risk from Cyclospora. Consumers should check their products for specific codes and dates.

    Product
    Fresh Express Premium Slaw Salad Kit Smoked BBQ Sriracha 11.1 oz., UPC 071279126029, Red and green cabbage, brussels sprouts, carrots, broccoli stalks
    Category
    Food
    Distribution
    32 states

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