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 deaths or serious injuries are reported, 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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2326–2350 of 5038

  • SevereFDA (Devices)·Z-2563-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Administration Sets

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

    Product
    BodyGuard Microset, REF: A120-161XYBS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2584-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2586-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America is recalling 13,280 CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.

    Product
    CMExpress Microbore Set, REF: A120-160C
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2569-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

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

    Product
    CMExpress Microbore Set, REF: A120-161CYF
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2562-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Administration Sets

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

    Product
    BodyGuard Microset, REF: A120-161XYB
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2570-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America, LLC is recalling BodyGuard Microset infusion administration sets because they may deliver fluids with an inaccuracy exceeding plus/minus 13%, risking over- or under-infusion of therapy.

    Product
    BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2631-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD RENU FLOW Bone Void Filler Kits

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

    Product
    SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2605-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

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

    Product
    CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2587-2020·2020-07-22

    CME America Recalls CMExpress Needleless Y Site Microbore Sets

    CME America is recalling 1,824 CMExpress Needleless Y Site Microbore Sets due to delivery inaccuracy that could cause over- or under-infusion of therapy.

    Product
    CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2585-2020·2020-07-22

    CME America Recalls Infusion Sets Due to Delivery Inaccuracy

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

    Product
    Standard BodySet with Needleless Connectors, REF: A120-125XS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2568-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

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

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

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

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

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

    CME America Recalls BodyGuard Microset Infusion Administration Sets

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

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

    CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2565-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard Microset, REF: A120-161XPSV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2596-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Impact Bone Void Filler Kits

    Skeletal Kinetics is recalling 41 units of Acumed Impact 5CC bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2632-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

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

    Product
    CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects cr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2601-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

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

    Product
    CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2613-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation EX Bone Void Filler Kits

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

    Product
    OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2611-2020·2020-07-22

    Medtronic Bone Void Filler Recalled for Potential Failure to Set Properly

    Skeletal Kinetics is recalling Medtronic Bone Void Filler kits that may not maintain setting characteristics, potentially increasing surgical time or causing bone formation issues.

    Product
    MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2572-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard Microset with Filter, REF: A100-164XESF
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-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