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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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Minimum severity

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

Clear filters

13326–13350 of 27471

  • HighFDA (Devices)·Z-2612-2020·2020-07-22

    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, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - 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-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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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…
    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…
    Category
    Medical Device
    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-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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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…
    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…
    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…
    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