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.

201–300 of 590

  • HighFDA (Food)·F-1054-2020·2020-07-22

    Fresh Express 3 Color Deli Cole Slaw Recalled for Cyclospora Risk

    Fresh Express is recalling 14 oz 3 Color Deli Cole Slaw due to a possible health risk from Cyclospora. Consumers should check their refrigerators for affected products.

    Product
    Fresh Express America's Fresh 3 Color Deli Cole Slaw" 14 oz, UPC 071279123004, (Canada UPC) 0 71279 12302 8 , Green cabbage, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1127-2020·2020-07-22

    Fresh Express Marketside Crisp Greens Recalled for Cyclospora Risk

    Fresh Express is recalling Marketside Crisp Greens salad products due to a possible health risk from Cyclospora.

    Product
    Marketside Crisp Greens 12 oz., UPC 681131387552, Romaine lettuce, red cabbage, iceberg lettuce & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2606-2020·2020-07-22

    Skeletal Kinetics Recalls Ossilix Fil Bone Void Filler Kits

    Skeletal Kinetics is recalling Ossilix Fil 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
    EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - 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-2630-2020·2020-07-22

    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, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - 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 (Devices)·Z-2552-2020·2020-07-22

    Bausch & Lomb Recalls enVista Toric Intraocular Lenses Due to Axis Misalignment

    Bausch & Lomb is recalling five enVista toric intraocular lenses because the toric axis marks were misaligned on an implanted lens.

    Product
    enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1119-2020·2020-07-22

    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 eat the product.

    Product
    Marketside Chopped Salad Kit Avocado Ranch 9.5 oz., UPC 681131221528, Green & red cabbage, kale, romaine lettuce, radish & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1090-2020·2020-07-22

    Fresh Express Coleslaw Recalled Due to Possible Cyclospora Risk

    Fresh Express is recalling Giant Eagle Coleslaw products due to a possible health risk from Cyclospora.

    Product
    Giant Eagle Lifes Getting Fresher Coleslaw 16 oz., UPC 030034923099, Green cabbage & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1134-2020·2020-07-22

    Fresh Express Marketside Tri-Color Cole Slaw Recalled for Cyclospora Risk

    Fresh Express is recalling Marketside Tri-Color Cole Slaw due to a possible health risk from Cyclospora. The product is sold in specific US states and Canada.

    Product
    Marketside Tri-Color Cole Slaw 16 oz., UPC 681131387484, Green & red cabbage and carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2620-2020·2020-07-22

    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, INJECT FORMULA. Product Number: 390-2005, UDI: 813845020054 - 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-1100-2020·2020-07-22

    Fresh Express Recalls Hy-Vee Avocado Ranch Salad Due to Cyclospora Risk

    Fresh Express is recalling Hy-Vee Chopped Kit Avocado Ranch Salad products due to a possible health risk from Cyclospora.

    Product
    Hy-Vee Chopped Kit Avocado Ranch Salad 12.8 oz., UPC 075450247152, Green cabbage, romaine lettuce, carrots, cilantro & green onions
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1097-2020·2020-07-22

    Fresh Express Shredded Lettuce Recalled for Cyclospora Risk

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

    Product
    Giant Eagle Shredded Lettuce 16 oz., UPC 030034923204, Iceberg lettuce
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2547-2020·2020-07-22

    DiaSorin Simplexa HSV 1&2 Direct Recalled Due to Software Malfunction

    DiaSorin Molecular LLC is recalling Simplexa HSV 1&2 Direct test kits because a software malfunction may cause false negative results.

    Product
    MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1078-2020·2020-07-22

    Fresh Express Premium Slaw Salad Kit Recalled for Cyclospora Risk

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

    Product
    Fresh Express Premium Slaw Salad Kit Honey Pecan 9.3 oz ., UPC 071279126036, Red and green cabbage, cauliflower stalks, mature kale, arugula
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2621-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovationex Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovationex 2cc Inject Formula bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - 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 (Devices)·Z-2629-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD FLOW Bone Void Filler Kits

    Skeletal Kinetics is recalling SKAFFOLD FLOW 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
    SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - 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
  • HighFDA (Devices)·Z-2627-2020·2020-07-22

    Skeletal Kinetics Recalls Skaflow Flow Bone Void Filler Kits

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

    Product
    SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - 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 osseou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2020·2020-07-22

    Medtronic Bone Void Filler Recalled for Potential Failure to Set

    Skeletal Kinetics is recalling Medtronic 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
    MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - 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
  • HighFDA (Food)·F-1092-2020·2020-07-22

    Fresh Express Garden Salad Blend Recalled for Cyclospora Risk

    Fresh Express is recalling Giant Eagle Garden Salad Blend due to a possible health risk from Cyclospora. Consumers should check their refrigerators for the affected product.

    Product
    Giant Eagle Life s Getting Fresher Fresh Garden Salad Blend 12 oz., UPC 030034923198, Iceberg lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • 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-1026-2020·2020-07-22

    Freshness Guaranteed Five Cheese Stuffed Shells Recalled for Listeria Risk

    Garland Ventures is recalling Freshness Guaranteed Five Cheese Stuffed Shells due to potential Listeria monocytogenes contamination.

    Product
    Freshness Guaranteed Five Cheese Stuffed Shells Traditional Italian Ricotta Filled Shells with Marinara Sauce 10.76 ounces UPC 7874235174
    Category
    Food
    Distribution
    Distributed nationwide
  • 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
  • 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 (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-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 (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 (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 (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-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-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 (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-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-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-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-1106-2020·2020-07-22

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

    Fresh Express is recalling Hy-Vee Greener Supreme Salad Mix due to a possible health risk from Cyclospora. Consumers should check their refrigerators for the affected product.

    Product
    Hy-Vee Greener Supreme Salad Mix 12 oz., UPC 075450120462, Iceberg lettuce, romaine lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1142-2020·2020-07-22

    Wegmans Pecan Blend Recalled for Undeclared Almonds and Walnuts

    Flagstone Foods LLC is recalling Wegmans Pecan Blend due to undeclared almonds and walnuts, posing a risk to individuals with allergies.

    Product
    Wegmans PECAN BLEND Supreme Pecans, Cashews & Pistachios NET WT 16 OZ(1 LB) 454g plastic bag Ingredients: Pecans, Cashews, Dry Roasted Pistachios, Peanut Oil, Salt. Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603 UPC 0 77890 31040 3
    Category
    Food
    Distribution
    6 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-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-2598-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits

    Skeletal Kinetics is recalling 48 units of Craniosculpt C bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - 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 trauma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Impact Bone Void Filler Kits

    Skeletal Kinetics is recalling 40 Acumed Impact bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - 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 traumatic injury to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V424000·2020-07-22

    Thor Motor Coach Sequence Motorhomes Dinette Seat Belt Tethers Too Short

    Thor Motor Coach is recalling certain 2020-2021 Sequence and Tellaro motorhomes because the dinette booth seat belt tethers are too short, preventing safe use by some occupants and increasing crash injury risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH TELLARO, SEQUENCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1108-2020·2020-07-22

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

    Fresh Express is recalling Hy-Vee Romaine Salad Mix due to a possible health risk from Cyclospora. Consumers should check their refrigerators for the affected product.

    Product
    Hy-Vee Romaine Salad Mix 12 oz., UPC 075450120585, Romaine lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1117-2020·2020-07-22

    Fresh Express Marketside Baby Greens Salad Recalled for Cyclospora Risk

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

    Product
    Marketside Baby Greens Salad 6 oz., UPC 681131027922, Baby spinach, carrots, baby lettuce blend & baby greens blend
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1093-2020·2020-07-22

    Fresh Express Italian Blend Salad Recalled for Cyclospora Risk

    Fresh Express is recalling Giant Eagle Italian Blend salads due to a possible health risk from Cyclospora. Consumers should not eat the product.

    Product
    Giant Eagle Life s Getting Fresher Fresh Italian Blend 9 oz., UPC 030034923112, Romaine lettuce & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1063-2020·2020-07-22

    Fresh Express American Salad Recalled Due to Possible Cyclospora Risk

    Fresh Express American salad products containing iceberg lettuce, red cabbage, or carrots are recalled due to a possible health risk from Cyclospora.

    Product
    Fresh Express American 11 oz.,UPC 071279241005, (Canada UPC) 0 71279 24100 5, Iceberg & romaine, carrots red cabbage & radish
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1139-2020·2020-07-22

    Fresh Express Signature Farms Premium Romaine Recalled for Cyclospora Risk

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

    Product
    Signature Farms Premium Romaine 9 oz., UPC 021130419166, Iceberg Lettuce, Romaine, red cabbage and carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1079-2020·2020-07-22

    Fresh Express Shredded Iceberg Lettuce Recalled for Cyclospora Risk

    Fresh Express is recalling specific lots of shredded iceberg lettuce due to a possible health risk from Cyclospora. Consumers should check their products against the listed codes and dates.

    Product
    Fresh Express SHREDS Iceberg 14 oz., UPC 071279152004, Shredded iceberg lettuce
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1083-2020·2020-07-22

    Fresh Express Ready-to-Eat Salads Recalled for Cyclospora Risk

    Fresh Express is recalling specific ready-to-eat salad products due to a possible health risk from Cyclospora. Consumers should check their products and discard them if they match the description.

    Product
    Giant Eagle American (Family Size) 24 oz., UPC 030034930370, Iceberg lettuce, romaine lettuce, carrots, red cabbage and radishes
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1075-2020·2020-07-22

    Fresh Express Premium Romaine Salad Recalled Due to Cyclospora Risk

    Fresh Express is recalling Premium Romaine salad products due to a possible health risk from Cyclospora. Consumers should check for specific product codes and dates.

    Product
    Fresh Express Premium Romaine / Lechuga Romana Especial 9 oz., UPC 071279108087, Romaine lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1025-2020·2020-07-22

    KIND Granola Recalled for Undeclared Sesame Seeds

    KIND LLC is recalling Oats & Honey Granola with Toasted Coconut because the product contains undeclared sesame seeds.

    Product
    ***KIND HEALTHY GRAINS***Oats & Honey Granola with Toasted Coconut***INGREDIENTS: Oats, tapioca syrup, brown rice, cane sugar, honey, millet, oat flour, coconut, canola oil, buchwheat, amaranth, molasses, quinoa, brown rice syrup, sea salt, Vitamine E***May contanin peanuts, tree
    Category
    Food
    Distribution
    42 states
  • HighFDA (Food)·F-1060-2020·2020-07-22

    Fresh Express Chopped Kit Poppyseed Recalled for Cyclospora Risk

    Fresh Express Incorporated is recalling Chopped Kit Poppyseed salads due to a possible health risk from Cyclospora.

    Product
    Fresh Express Chopped Kit Poppyseed 11.7 oz, UPC 071279309118, Red and green cabbage, green leaf lettuce, carrots & green onions
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1057-2020·2020-07-22

    Fresh Express Chopped Kit BBQ Ranch Recalled for Cyclospora Risk

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

    Product
    Fresh Express Chopped Kit BBQ Ranch 11.3 oz, UPC 071279309071,Green cabbage, cauliflower, kale, red cabbage & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1024-2020·2020-07-22

    Whole Foods Market Red Velvet Cheesecake Recalled for Undeclared Walnuts

    Whole Foods Market is recalling Red Velvet Layered Cheesecake Slices due to undeclared walnuts. The recall covers 287 units sold in California, Idaho, and Nevada.

    Product
    Whole Foods Market Red Velvet Layered Cheesecake Slice PLU: 78620 packaged in plastic clam shell with scale label applied
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1081-2020·2020-07-22

    Fresh Express Veggie Lover's Salad Recalled for Cyclospora Risk

    Fresh Express is recalling Veggie Lover's salad due to a possible health risk from Cyclospora. Consumers should not eat the product.

    Product
    Fresh Express Veggie Lover's 11 oz., UPC 071279281001, (Canada UPC) 0 71279 28106 3, Iceberg & romaine lettuce, carrots, pea pods, red cabbage & radishes
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1073-2020·2020-07-22

    Fresh Express Italian Salad Recalled Due to Cyclospora Risk

    Fresh Express is recalling Italian salad products containing iceberg lettuce, red cabbage, or carrots due to a possible health risk from Cyclospora.

    Product
    Fresh Express Italian 9 oz., UPC 071279211008, Romaine lettuce & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1089-2020·2020-07-22

    Fresh Express Sunflower Crisp Salad Kit Recalled for Cyclospora Risk

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

    Product
    Giant Eagle Chopped Sunflower Crisp Salad Kit 11.1 oz., UPC 030034923396, Cabbage, kale, lettuce & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1130-2020·2020-07-22

    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 US states and Canada.

    Product
    Marketside Premium Romaine Salad 18 oz., UPC 681131388078, Romaine lettuce, red cabbage & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1084-2020·2020-07-22

    Fresh Express Recalls Giant Eagle Asian Style Salad Kits Due to Cyclospora Risk

    Fresh Express is recalling Giant Eagle Chopped Asian Style Salad Kits due to a possible health risk from Cyclospora. Consumers should check their refrigerators for the affected product.

    Product
    Giant Eagle Chopped Asian Style Salad Kit 12 oz., UPC 030034923310, Cabbage and lettuce, carrots, and green onion
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1098-2020·2020-07-22

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

    Fresh Express is recalling Hy-Vee American Salad Mix due to a possible health risk from Cyclospora. Consumers should check their refrigerators for the affected product.

    Product
    Hy-Vee American Salad Mix 12 oz., UPC 075450120479 , Iceberg lettuce, romaine lettuce, carrots, red cabbage & radishes
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1055-2020·2020-07-22

    Fresh Express Asian Salad Kits Recalled for Cyclospora Risk

    Fresh Express is recalling Chopped Kit Asian 12 oz products due to a possible health risk from Cyclospora contamination.

    Product
    Fresh Express Chopped Kit Asian 12 oz, UPC 071279302027, (Canada UPC) 0 71279 30929 3, Red and green cabbage, green leaf lettuce, carrots & green onions
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1113-2020·2020-07-22

    Fresh Express Little Salad Bar Coleslaw Recalled for Cyclospora Risk

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

    Product
    Little Salad Bar Classic Coleslaw 14 oz., UPC 041498302177, Green cabbage & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1051-2020·2020-07-22

    Fresh Express Garden Salad Recalled Due to Possible Cyclospora Risk

    Fresh Express is recalling Signature Farms Garden Salad products due to a possible health risk from Cyclospora. The recall affects 12 oz bags distributed in 33 US states and Canada.

    Product
    Signature Farms Garden Salad, 12 oz, UPC 021130981359, Iceberg lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighCPSC·20155·2020-07-22

    DownEast Recalls Folding Mattresses for Fire Hazard

    DownEast Outfitters is recalling Mattress on the Go folding mattresses because they fail to meet federal flammability standards, posing a fire hazard.

    Product
    Mattress on the Go folding mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2582-2020·2020-07-22

    CME America BodyGuard Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard set with Female Luer, REF: A120-003XSN
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2574-2020·2020-07-22

    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 therapy with an inaccuracy exceeding plus/minus 13%, potentially causing over- or under-infusion.

    Product
    BodyGuard Microset, REF: A100-163XSL
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2556-2020·2020-07-22

    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: A100-163XES
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2554-2020·2020-07-22

    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 therapy with an inaccuracy exceeding plus/minus 13%, potentially causing over- or under-infusion.

    Product
    BodyGuard Microset, REF: A120-160XPS
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Food)·F-1052-2020·2020-07-22

    Fresh Express Little Salad Bar Garden Recalled for Cyclospora Risk

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

    Product
    Little Salad Bar Garden, 12 oz, UPC 4099100082975, Iceberg lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1067-2020·2020-07-22

    Fresh Express Mediterranean Salad Recalled for Cyclospora Risk

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

    Product
    Fresh Express Gourmet Cafe Creative Classics Mediterranean 5.12 oz., UPC 071279407142, Red cabbage & romaine lettuce
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1102-2020·2020-07-22

    Fresh Express Southwest Salad Recalled for Cyclospora Risk

    Fresh Express is recalling Hy-Vee Chopped Kit Southwest Salad due to a possible health risk from Cyclospora. Consumers should not eat the product.

    Product
    Hy-Vee Chopped Kit Southwest Salad 13.4 oz., UPC 075450246698, Red & green cabbage, green leaf lettuce, carrots & green onions
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1121-2020·2020-07-22

    Fresh Express Marketside Chopped Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Marketside Chopped Salad Kit Kale Pecan Cranberry due to a possible health risk from Cyclospora.

    Product
    Marketside Chopped Salad Kit Kale Pecan Cranberry 7 oz., UPC 681131221320, Kale
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1086-2020·2020-07-22

    Fresh Express Chopped Chipotle Cheddar Salad Kit Recalled for Cyclospora Risk

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

    Product
    Giant Eagle Chopped Chipotle Cheddar Salad Kit 11.4 oz., UPC 030034923389, Cabbage and lettuce, carrots, and green onion
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1114-2020·2020-07-22

    Fresh Express Garden Salad Recalled Due to Cyclospora Risk

    Fresh Express is recalling Little Salad Bar Garden Salad products due to a possible health risk from Cyclospora.

    Product
    Little Salad Bar Garden Salad 12 oz.,UPC 4099100082975, Iceberg lettuce, carrots & red cabbage
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2602-2020·2020-07-22

    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, potentially increasing surgical time or causing bone formation issues.

    Product
    CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - 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 (Devices)·Z-2614-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation Impact Bone Void Filler Kits

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

    Product
    OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - 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 de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2549-2020·2020-07-22

    DiaSorin Simplexa VZV Swab Direct Recalled for Software Malfunction

    DiaSorin Molecular LLC is recalling Simplexa VZV Swab Direct kits due to a software malfunction that may cause false negative results.

    Product
    MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2020·2020-07-22

    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 5CC. Product Number: 390-6001, UDI: 813845021082 - 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-2581-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to 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 Male Luer Connectors, REF: A100-163XEBF
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2626-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD CMF Impress Bone Void Filler Kits

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

    Product
    SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - 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 (Devices)·Z-2551-2020·2020-07-22

    Roche MagNA Pure 96 Instrument Recalled for Cross-Contamination Risk

    Roche is recalling 917 MagNA Pure 96 instruments because a specific protocol version fails to activate the drop catcher, posing a risk of cross-contamination and erroneous results.

    Product
    MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2624-2020·2020-07-22

    Skeletal Kinetics Recalls SK Scaffold Impress 10CC Bone Void Filler Kits

    Skeletal Kinetics is recalling SK Scaffold Impress 10CC bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - 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-1101-2020·2020-07-22

    Fresh Express Recalls Hy-Vee Chopped Kit Chipotle Cheddar Salad

    Fresh Express is recalling Hy-Vee Chopped Kit Chipotle Cheddar Salad products due to a possible health risk from Cyclospora.

    Product
    Hy-Vee Chopped Kit Chipotle Cheddar Salad 11.4 oz., UPC 075450246728, Green & red cabbage & green onions
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1122-2020·2020-07-22

    Fresh Express Marketside Chopped Salad Kit Recalled for Cyclospora Risk

    Fresh Express is recalling Marketside Chopped Salad Kit Southwest due to a possible health risk from Cyclospora. Consumers should not consume the product.

    Product
    Marketside Chopped Salad Kit Southwest 13.4 oz., UPC 681131007061, Green & red cabbage, kale, romaine lettuce, kale, green onions & carrots
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2622-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovationex Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovationex 5cc 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
    OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - 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-2625-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD CMF Impress Bone Void Filler Kits

    Skeletal Kinetics is recalling 12 units of SKAFFOLD CMF Impress bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - 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 (Devices)·Z-2607-2020·2020-07-22

    Exactech Ossilix Fil Bone Void Filler Recalled for Setting Defects

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

    Product
    EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - 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 (Devices)·Z-2593-2020·2020-07-22

    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 3CC. Product Number: 65-0003-S, UDI: 813845020221 - 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 fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2599-2020·2020-07-22

    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.

    Product
    CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - 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-2604-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling 35 units of Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - 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 (Devices)·Z-2634-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits

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

    Product
    CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - 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
  • HighFDA (Devices)·Z-2623-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovationex Bone Void Filler Kits

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

    Product
    OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - 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 (Devices)·Z-2618-2020·2020-07-22

    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, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 813845020078 - 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 (Devices)·Z-2548-2020·2020-07-22

    DiaSorin Simplexa VZV Direct Recalled for Potential False Negative Results

    DiaSorin Molecular LLC is recalling Simplexa VZV Direct test kits due to a software malfunction that may cause false negative results for varicella-zoster virus.

    Product
    MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2609-2020·2020-07-22

    Skeletal Kinetics Recalls Ossilix Form Bone Void Filler Kits

    Skeletal Kinetics is recalling 15 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), 5CC. Product Number: 660-01-05, UDI: 813845021020 - 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
  • ModerateFDA (Devices)·Z-2637-2020·2020-07-22

    Neocis Dental Chairside Splints Recalled for Potential Mislabeling

    Neocis Inc. is recalling specific dental chairside splints because they may be mislabeled. The recall covers 70 units distributed nationwide.

    Product
    DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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