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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13776–13800 of 13802

  • HighFDA (Devices)·Z-1712-2021·2021-06-09

    ZVplasty Direct Access Trocar Recalled for Inadequate Sterilization

    Zavation is recalling ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) because some units may not be adequately sterilized. These surgical instruments are used in orthopedic and spinal procedures.

    Product
    ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2021·2021-06-09

    ZVplasty Drill units may not have been adequately sterilized

    Zavation recalled ZVplasty Drill units (REF VCF-1006, batch 19113036) distributed nationwide. The 38 affected units may not have been adequately sterilized, creating a risk of infection.

    Product
    ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2021·2021-06-09

    Nimbus alternating-pressure mattress overlay system recall for inflation malfunction

    Getinge is recalling approximately 13,042 units of Nimbus 4 and Nimbus Professional alternating-pressure mattress overlays due to potential abnormal inflation that could impair pressure relief function.

    Product
    Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1723-2021·2021-06-09

    ZVplasty Biopsy Device Recalled Due to Inadequate Sterilization

    Zavation's ZVplasty Biopsy Device (11 Gauge, lot 20061370) is being recalled because distributed units may not have been adequately sterilized. The 34 affected units were distributed nationwide.

    Product
    ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1782-2021·2021-06-09

    Tranberg Laser Applicator Devices Recalled Due to Inadequate Sterilization

    Clinical Laserthermia Systems recalls 90 units of Tranberg Laser Applicator devices distributed worldwide because single-use sterile devices may not have been adequately sterilized.

    Product
    Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1726-2021·2021-06-09

    ZVplasty Directional Cement Cannula recalled for inadequate sterilization

    Zavation is recalling 11 units of ZVplasty Directional Cement Cannula from lot 20061366 because products distributed as sterile may not have been adequately sterilized. The affected devices were distributed nationwide.

    Product
    ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2021·2021-06-09

    Cement Delivery Cannula May Not Be Adequately Sterilized

    Zavation is recalling 10 gauge cement delivery cannulas (INTVM-CDC) used in orthopedic procedures because distributed products may not have been adequately sterilized. The recall affects 130 units distributed nationwide.

    Product
    10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1725-2021·2021-06-09

    ZVplasty Directional Cement Cannula Long may lack adequate sterilization

    Zavation is recalling 27 units of ZVplasty Directional Cement Cannula Long (Lot 20061365) used in orthopedic and spinal procedures due to inadequate sterilization. Products were distributed nationwide as sterile but may not have undergone proper sterilization processing.

    Product
    ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1757-2021·2021-06-09

    ZVplasty System spinal implant devices recalled for inadequate sterilization

    Zavation is recalling 31 ZVplasty System spinal implant devices that may not have been adequately sterilized. Patients who received these implants should contact their physician.

    Product
    ZVplasty System, 10mm, Pat# VCF-1010-2. 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-1713-2021·2021-06-09

    Zavation surgical bone access kit recalled due to inadequate sterilization

    Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Patients who received these devices should contact their healthcare provider.

    Product
    ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2021·2021-06-09

    MiniMed 670G Insulin Pump Software Flaw Risks Insulin Overdose

    A software design issue in the MiniMed 670G insulin pump may cause insulin overdose when users are unaware of active insulin levels. Medtronic is recalling clinical study devices.

    Product
    MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 0
    Category
    Medical Device
    Distribution
    12 states
  • 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-1705-2021·2021-06-09

    ZVplasty Cement Delivery Cannulas Recalled for Inadequate Sterilization

    Zavation recalled 14 units of ZVplasty Bipedicular Cement Delivery Cannula Kits distributed nationwide because they may not have been adequately sterilized.

    Product
    ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1719-2021·2021-06-09

    Zavation Direct Working Cannula Recalled for Sterilization Defect

    Zavation is recalling 58 units of 11G Direct Working Cannula Diamond Tip Mini devices (Lot 2002437) because they may not have been adequately sterilized before distribution.

    Product
    11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1738-2021·2021-06-09

    Zavation 10G Direct Double Bone Access Kit May Not Be Properly Sterilized

    Zavation recalled its 10G Direct Double Bone Access Kit used in orthopedic surgery because products distributed as sterile may not have been adequately sterilized, potentially exposing patients to infection.

    Product
    10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2021·2021-06-09

    Draeger Babylog VN600 Critical Care Ventilators Recalled for Software Defects

    Draeger Medical is recalling Babylog VN600 ventilators due to three software issues: unexpected unit restarts, incorrect oxygen-level alarms, and failure of the automated weaning protocol. These defects could affect patient care and safety.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2021·2021-06-09

    11G Beveled Trocars and Cannulas Recalled for Possible Inadequate Sterilization

    Zavation is recalling 11G Beveled Trocars/Cannulas for orthopedic and spinal procedures. These surgical instruments may not have been adequately sterilized, posing a potential safety risk.

    Product
    11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2021·2021-06-09

    Orthopedic Cement Delivery Kits Recalled Due to Sterilization Concerns

    Zavation's 10G cement delivery kits for spinal procedures may not be adequately sterilized despite being marketed as sterile. Patients and healthcare providers should contact Zavation regarding potentially affected units.

    Product
    10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). 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-1731-2021·2021-06-09

    10 Gauge Drill for Orthopedic Surgery Recalled for Sterilization Failure

    Zavation recalled 58 units of 10 Gauge Drill (Lot 20102486) used in orthopedic/spinal procedures due to potential inadequate sterilization. Patients should contact their surgeon if they received treatment with an affected device.

    Product
    10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1789-2021·2021-06-09

    Terumo HX2 and TCM Temperature Management Systems Recalled for Cleaning Protocol Issues

    Terumo recalled the HX2 and TCM temperature management systems used in cardiac surgery due to inability to validate an updated cleaning protocol. Users should discontinue use and properly dispose of affected devices.

    Product
    The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1691-2021·2021-06-09

    Draeger Evita V800 Ventilator Recalled for Multiple Software Defects

    Draeger Medical is recalling the Evita V800 critical care ventilator due to three unrelated software defects affecting ventilation delivery and alarm functionality.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2021·2021-06-09

    Critical care ventilators recalled for software defects affecting alarm and operation

    Draeger Medical is recalling critical care ventilators due to software defects that can cause the device to restart, display incorrect oxygen alarms, and suspend weaning protocols. No patient injuries have been reported.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1699-2021·2021-06-09

    NexSite HD hemodialysis catheter directions for use consistency recall

    MARVAO MEDICAL DEVICES is correcting the Directions for Use (DFU) for NexSite HD hemodialysis catheters to ensure consistency between field documentation and website information for 292 devices distributed in the U.S.

    Product
    NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
    Category
    Medical Device
    Distribution
    4 states