The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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Any3+ (High and above)4+ (High and above)5+ (High and above)

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13326–13350 of 27500

  • 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…
    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…
    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-2617-2020·2020-07-22

    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, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits

    Skeletal Kinetics is recalling 27 units of Craniosculpt bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - 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-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-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 (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-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 (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
  • 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 (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 (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 (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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2504-2020·2020-07-15

    CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cages Due to Fracturing

    CTL Medical Corporation is recalling 46 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.

    Product
    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2501-2020·2020-07-15

    CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracturing

    CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cage because reports indicate the device fractured during insertion.

    Product
    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2489-2020·2020-07-15

    Prodimed Combicath Catheters Recalled for Sterility Assurance Concerns

    Prodimed Plastimed Division is recalling 300 Combicath catheters nationwide due to a lack of assurance of sterility.

    Product
    Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2502-2020·2020-07-15

    CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracture Reports

    CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.

    Product
    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2503-2020·2020-07-15

    CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracturing

    CTL Medical Corporation is recalling 45 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.

    Product
    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2491-2020·2020-07-15

    Prodimed Combicath Paediatric Catheters Recalled Due to Sterility Assurance Issues

    Prodimed Plastimed Division is recalling 180 units of Combicath Paediatric catheters nationwide because the company cannot assure the sterility of the devices.

    Product
    Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
    Category
    Medical Device
    Distribution
    Distributed nationwide