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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11651–11675 of 27470

  • HighFDA (Devices)·Z-1715-2021·2021-06-09

    Orthopedic spinal surgical device may lack adequate sterilization

    Zavation is recalling its 10G DIRECT SINGLE - ACCESS device used in spinal surgery. Products distributed as sterile may not have been adequately sterilized.

    Product
    10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1720-2021·2021-06-09

    Zavation spinal orthopedic cement delivery kits recalled for inadequate sterilization

    Zavation is recalling 122 units of sterile orthopedic cement delivery kits that may not have been adequately sterilized. The kits were distributed nationwide for use in spinal and orthopedic procedures.

    Product
    10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2021·2021-06-09

    ZVplasty Direct Access Bevel Tip Trocar Recalled Due to Inadequate Sterilization

    Zavation is recalling ZVplasty Direct Access Bevel Tip Trocars used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. The recall affects 98 units distributed nationwide.

    Product
    ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2021·2021-06-09

    ZVplasty Cement Delivery Cannula Recalled Due to Sterilization Failure

    Zavation recalls 22 ZVplasty Cement Delivery Cannulas (lot 20102490) distributed nationwide because they may not have been adequately sterilized for use in orthopedic and spinal procedures.

    Product
    ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2021·2021-06-09

    Oral Surgery Scrapers Recalled Due to Potential Sterility Failure

    Meta C.G.M. Spa is recalling the REF 3987 SafeScraper Curve Twist oral surgical scrapers distributed in Texas and Florida due to sterility concerns. The single-use sterile devices may not have been adequately sterilized.

    Product
    REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1689-2021·2021-06-09

    Vygon Dressing Change Kit Recalled for Sterile Barrier Failure Risk

    Vygon U.S.A. is recalling 8,320 units of its Dressing Change w/ Maxiswab kit due to improper adhesion of the sterile Tyvek lid to the tray, which could compromise the sterile barrier and potentially cause infection.

    Product
    Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2021·2021-06-09

    ZVplasty Bone Access Kit Recalled for Inadequate Sterilization

    Zavation has recalled the ZVplasty Direct Unipedicular Bone Access Kit with Drill due to potential sterilization failure. The surgical device is used in orthopedic and spinal procedures, with 11 units distributed nationwide.

    Product
    ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2021·2021-06-09

    Zavation ZVplasty Orthopedic System Recalled for Inadequate Sterilization

    Zavation's ZVplasty System surgical devices may not have been adequately sterilized, creating infection risk. The recall affects 195 units distributed nationwide in the US across multiple lot numbers.

    Product
    ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1761-2021·2021-06-09

    Spinal surgery implant kit recalled for inadequate sterilization

    Zavation is recalling ZVplasty 10G spinal implant kits that may not have been properly sterilized. The affected devices were distributed nationwide and may pose infection risk if implanted.

    Product
    ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2021·2021-06-09

    Philips BRILLIANCE VOLUME CT System cooling unit may eject from gantry

    A cooling unit in the Philips BRILLIANCE VOLUME computed tomography system may unexpectedly eject from the gantry, posing a risk of injury. Two affected units are being recalled.

    Product
    BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2021·2021-06-09

    Zavation Orthopedic Stylet Recalled for Inadequate Sterilization

    Zavation is recalling 56 units of 10 gauge direct unilateral stylets used in spinal procedures because products distributed as sterile may not have been adequately sterilized. Affected units were distributed nationwide.

    Product
    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2021·2021-06-09

    Orthopedic spinal implants recalled due to inadequate sterilization

    Zavation is recalling 7 units of 11G DIRECT SINGLE spinal implants (lots 2001185 and 2001243) because products distributed as sterile may not have been adequately sterilized. The devices were distributed nationwide.

    Product
    11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2021·2021-06-09

    Oral surgery scraper devices recalled due to inadequate sterilization

    Meta C.G.M. is recalling 150 units of SAFESCRAPER TWIST oral surgery instruments distributed in Texas and Florida due to sterility defects. Single-use sterile devices may not have been adequately sterilized, creating a risk of infection.

    Product
    REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1771-2021·2021-06-09

    MiniMed 780G Insulin Pump Software Fault Risks Overdose

    A software design flaw in the MiniMed 780G Insulin Pump can cause insulin over-delivery. If users deliver an additional bolus without knowing their active insulin level, they risk receiving too much insulin.

    Product
    MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL;¿ KIT MMT-1896WW MM780G 6.5W BLE SF MG;¿ PUMP MMT-1884XC 780G V6.5 CLIN US MG;¿ PUMP MMT-1885XC 780G V6.5 CLIN MM;¿ PUMP…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1743-2021·2021-06-09

    10G Direct Single Bone Access Kits recalled for sterilization failure

    Zavation's 10G Direct Single Bone Access Kits are being recalled because products distributed as sterile may not have been adequately sterilized, posing infection risk in orthopedic procedures.

    Product
    10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1791-2021·2021-06-09

    Terumo Sarns TCM II cardiac temperature controller cleaning protocol failure

    The Sarns TCM II temperature control system used in cardiac surgery has been recalled due to inability to validate its cleaning protocol. Users are instructed to discontinue use and dispose of all affected devices.

    Product
    The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1773-2021·2021-06-09

    Change Healthcare Enterprise Viewer software defect affects image display settings

    A software defect in Change Healthcare Enterprise Viewer versions 2.0 and 2.1 prevents the display of image presentation styles. The viewer is used nationwide for displaying medical images.

    Product
    Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2021·2021-06-09

    Oral Surgery Devices Recalled for Potential Sterility Failures

    Meta C.G.M. Spa is recalling MICROSS oral surgery devices due to sterility concerns. Units labeled as sterile may not have been adequately sterilized.

    Product
    REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1625-2021·2021-06-02

    Philips Respironics BiPAP V30 Auto Recall for Non-Conforming Plastic Material

    Philips Respironics is recalling 22 BiPAP V30 Auto ventilators because non-conforming plastic in motor assemblies may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1628-2021·2021-06-02

    Philips Respironics BiPAP A40 System Silver Recalled for Motor Assembly Defect

    Philips Respironics is recalling four BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may off-gas or fail, posing asphyxia risks.

    Product
    BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1630-2021·2021-06-02

    Philips Respironics BiPAP A40 Ventilator Recall for Material Defects

    Philips Respironics is recalling four BiPAP A40 ventilators because non-conforming plastic in the motor assembly may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1626-2021·2021-06-02

    Philips Respironics BiPAP A40 Ventilators Recalled for Motor Assembly Defects

    Philips Respironics is recalling 10 BiPAP A40 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1627-2021·2021-06-02

    Philips BiPAP A40 System Silver Recalled for Motor Assembly Defects

    Philips Respironics is recalling specific BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may cause off-gassing or sudden device failure.

    Product
    BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1629-2021·2021-06-02

    Philips Respironics BiPAP A30 Ventilator Recall for Motor Assembly Defect

    Philips Respironics is recalling two BiPAP A30 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2021·2021-06-02

    Radiometer Recalls PICO70 Arterial Blood Samplers Due to Sterile Barrier Breach

    Radiometer is recalling PICO70 Arterial Blood Samplers because a sterile barrier breach was found during testing, posing a risk of bacterial infection.

    Product
    PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518…
    Category
    Medical Device
    Distribution
    Distributed nationwide