The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

20176–20200 of 50413

  • HighFDA (Devices)·Z-1841-2021·2021-06-16

    Medline Tissue Recovery Instrument Sets Recalled for Sterility Assurance Failure

    Medline Industries is recalling Tissue Recovery Instrument Sets due to failure to meet sterility assurance levels. The instruments, used for tissue recovery in medical research and transplantation, were distributed in Wisconsin.

    Product
    Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1808-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate System Screw Mechanism May Disassociate

    Alphatec Spine is recalling Insignia Anterior Cervical Plate Systems due to a potential defect where the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. No patient injuries have been reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2021·2021-06-16

    Medical Device Illumination Pack Recalled Due to Burn and Occlusion Risks

    Nico Corp. is recalling 439 NICO Myriad-LX Illumination Packs used in surgical procedures due to potential delivery sleeve occlusion and thermal burn injury from the fiber tip assembly.

    Product
    NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1800-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System screw mechanism failure

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate or unlock during or after spine surgery, potentially compromising implant stability.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V450000·2021-06-15

    2022 IC Bus school buses lack required emergency exit windows

    Navistar is recalling certain 2014–2022 IC Bus school buses that lack adequate emergency exit windows required by federal safety standards. The deficiency could delay passenger evacuation during emergencies.

    Product
    IC BUS — IC BUS CASB, CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V447000·2021-06-14

    Kia K5 2021-2022 steering system defect increases crash risk

    Kia is recalling certain 2021-2022 K5 models with a power steering defect. The steering system may lose assist while driving due to a communication fault, increasing crash risk.

    Product
    KIA — KIA K5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V446000·2021-06-13

    Rossmonster Ram Promaster Recall for Potential Gas Leak Fire Risk

    Rossmonster is recalling 2018 Ram Promaster vans because an overtightened saddle valve bolt may damage the o-ring seal, causing a gas leak that increases fire risk.

    Product
    ROSSMONSTER — ROSSMONSTER RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V443000·2021-06-11

    2021 Forest River Wildwood and Salem Trailer Clearance Lamp Defect

    Forest River is recalling 2021 Wildwood and Salem trailers because red and amber clearance lamps do not reflect enough light. This visibility defect increases the risk of crashes with other vehicles.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V444000·2021-06-11

    2021 East to West Alta Travel Trailers: LP/CO Detector Placement Recall

    Forest River is recalling 2021 East to West Alta travel trailers because the LP/CO detector was installed in the incorrect location. This impairs propane leak and carbon monoxide detection, increasing fire and injury risks.

    Product
    EAST TO WEST — EAST TO WEST ALTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V438000·2021-06-10

    2021 RAM 1500 rearview camera may fail to display, increasing crash risk

    Certain 2021 RAM 1500 vehicles may have a rearview camera that doesn't display due to a software issue in the trailer reverse steering module. This reduces rear visibility and increases the risk of crashes.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V441000·2021-06-10

    Thor Motor Coach Motorhomes Recalled for Missing LP Tank Heat Shield

    Thor Motor Coach is recalling 2018-2022 Axis and 2018-2021 Vegas motorhomes with missing heat shields between the LP tank and chassis muffler. A missing heat shield increases fire risk; dealers will install the shield free of charge.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH AXIS, VEGAS, redundant AXIS, redundant VEGAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V440000·2021-06-10

    Emergency jack fracture risk affects Chevrolet Trailblazer and Buick Encore GX

    General Motors is recalling approximately 135,400 certain 2020-2022 Buick Encore GX and 2021-2022 Chevrolet Trailblazer vehicles because their emergency jacks can fracture if not positioned correctly, risking vehicle collapse.

    Product
    CHEVROLET — CHEVROLET, BUICK TRAILBLAZER, ENCORE GX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21753·2021-06-10

    2021 Can-Am Outlander and Renegade ATVs Recalled for Crash Hazard

    BRP is recalling about 4,600 model year 2021 Can-Am Outlander and Renegade ATVs because the steering knuckle can detach from the lower arm, causing loss of control and crash risk.

    Product
    2021 Can-Am Outlander and Renegade ATVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21754·2021-06-10

    Children's Barhee Fishing Hero Toy Games Recalled for Excessive Lead Content

    Blue Star Trading is recalling about 300 Barhee Fishing Hero toy games sold on Amazon.com because metal rollers on the flying dinosaur figures contain lead levels exceeding the federal ban. Lead is toxic to young children if ingested.

    Product
    Children's Barhee Fishing Hero Toy Games
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V421000·2021-06-10

    2021 Buick Envision air bag warning lamp may fail to illuminate

    GM is recalling 2021 Buick Envision vehicles—the air bag warning lamp may fail to illuminate due to a module defect. Owners should contact their dealer for a free software update.

    Product
    CHEVROLET — CHEVROLET, CADILLAC, GMC SUBURBAN, ESCALADE ESV, ESCALADE, YUKON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-1753-2021·2021-06-09

    Orthopedic Spinal Surgery Kit Recalled for Inadequate Sterilization

    Zavation is recalling InterV CurvePlus surgical kits because products distributed as sterile may not have been adequately sterilized. 36 units were distributed nationwide.

    Product
    InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. 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-1775-2021·2021-06-09

    Synapse Cardiovascular software may incorrectly reuse patient database identifiers

    Fujifilm's Synapse Cardiovascular software versions 6.0.4 to 6.2.1 contain a defect in the Advanced Reporting function where previously assigned patient database identification numbers can be reused for new patients when specific patient merge operations are executed.

    Product
    Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1763-2021·2021-06-09

    ZVplasty 10G FLEX Kyphoplasty Spinal Device Recall Due to Sterilization Failure

    Zavation is recalling 19 units of ZVplasty 10G FLEX KYPHOPLASTY spinal devices because distributed units may not have been adequately sterilized, posing infection risk to patients.

    Product
    ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2021·2021-06-09

    Zavation InterV 10G kyphoplasty kits recalled due to inadequate sterilization

    Zavation is recalling InterV 10G Kyphoplasty Kits because products distributed as sterile may not have been adequately sterilized. The recall affects 503 units distributed nationwide.

    Product
    InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide