The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

22651–22675 of 50430

  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1103-2020·2020-07-22

    Fresh Express Sunflower Crunch Salad Recalled for Cyclospora Risk

    Fresh Express is recalling Hy-Vee Chopped Kit Sunflower Crunch Salad due to a possible health risk from Cyclospora.

    Product
    Hy-Vee Chopped Kit Sunflower Crunch Salad 13.2 oz., UPC 075450246704, Green & red cabbage, kale, green leaf lettuce, carrots & sweet onions
    Category
    Food
    Distribution
    32 states
  • 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 (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 (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 (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…
    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…
    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…
    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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20154·2020-07-22

    BioMed Balance Recalls Essential Oils for Non-Child-Resistant Packaging

    BioMed Balance is recalling Wintergreen and Sweet Birch Essential Oils because the packaging is not child-resistant, posing a poisoning risk.

    Product
    BioMed Balance Wintergreen and Birch Tar Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • 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-1069-2020·2020-07-22

    Fresh Express Green & Crisp Salads Recalled for Cyclospora Risk

    Fresh Express is recalling Green & Crisp salad products containing iceberg lettuce, red cabbage, and carrots due to a possible health risk from Cyclospora.

    Product
    Fresh Express Green & Crisp / Verde y Crujiente 11 oz., UPC 071279108049, (Canada UPC) 0 71279 10813 1, Iceberg & romaine lettuce, carrots & red cabbage
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1064-2020·2020-07-22

    Fresh Express Fancy Greens Recalled for Possible Cyclospora Contamination

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

    Product
    Fresh Express Fancy Greens 7 oz., UPC 071279232010, Romaine lettuce, green tango, radicchio & carrots
    Category
    Food
    Distribution
    32 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 (Devices)·Z-2628-2020·2020-07-22

    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 incomplete bone formation.

    Product
    SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - 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
  • 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-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