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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22676–22700 of 40299

  • SevereFDA (Devices)·Z-2980-2018·2018-09-12

    Medline Recalls LASER CDS Surgical Packs with Non-Sterile Applicators

    Medline Industries is recalling 144 LASER CDS surgical kits because specific ChloraPrep applicators were not sterilized. The non-sterile components were inadvertently released to California and New Mexico.

    Product
    LASER CDS
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2962-2018·2018-09-12

    Bayer Medical Care Recalls Overhead Counterpoise Systems Due to Structural Risk

    Bayer Medical Care is recalling four Overhead Counterpoise Systems because overtightened bolts may compromise structural integrity, posing a risk of injury.

    Product
    Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2961-2018·2018-09-12

    Bayer Overhead Counterpoise Systems Recalled for Potential Structural Failure

    Bayer Medical Care is recalling one Overhead Counterpoise System unit due to potential overtightening of bolts that could compromise structural integrity.

    Product
    Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2960-2018·2018-09-12

    Bayer Overhead Counterpoise Systems Recalled for Potential Structural Failure

    Bayer Medical Care is recalling two Overhead Counterpoise Systems because overtightened bolts may compromise structural integrity, posing a risk of injury.

    Product
    Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2977-2018·2018-09-12

    Medline Recalls Sterile PICC Trays Due to Non-Sterile Component

    Medline Industries is recalling sterile PICC trays because a non-sterile component was attached to the outside of the packaging, posing a potential infection risk.

    Product
    PICC Tray, STERILE, 12 packs each per case.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2968-2018·2018-09-12

    McKesson Cardiology Hemo Software Recalled for Signal Display Issues

    McKesson Israel Ltd. is recalling McKesson Cardiology Hemo software version 13.0 because the Real Time Monitor may fail to display physiological signals under certain circumstances.

    Product
    McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2959-2018·2018-09-12

    Steris Recalls V-PRO Low Temperature Sterilization Systems Due to Sterilant Expiration Defect

    Steris Corporation is recalling 2,889 V-PRO low temperature sterilization systems because they may fail to detect expired sterilant cups after a power cycle.

    Product
    AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2992-2018·2018-09-12

    Hitachi VidiStar PACS Software Recalled for Potential Image Mix-Up

    Hitachi is recalling VidiStar PACS software versions 3.10.5 and 3.10.6 because a defect may cause images from multiple patients to appear in a single study.

    Product
    VidiStar(TM) PACS & DICOM Viewer Software system
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2989-2018·2018-09-12

    GE Vivid 7 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling 12,426 Vivid 7 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.

    Product
    GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2988-2018·2018-09-12

    GE Vivid E95 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling 12,426 Vivid E95 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.

    Product
    GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2987-2018·2018-09-12

    GE Vivid E90 Ultrasound System Recalled for Electrical Shock Risk

    GE Medical Systems is recalling Vivid E90 ultrasound systems because the power cord may break and expose electrical conductors, posing a risk of shock.

    Product
    GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2984-2018·2018-09-12

    GE LOGIQ 9 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling 12,426 LOGIQ 9 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.

    Product
    GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2976-2018·2018-09-12

    Medline Recalls Art-Line Surgery Packs Due to Non-Sterile Component

    Medline is recalling 3,000 Art-Line Surgery Packs because a non-sterile CHG disk was attached to the outside of the sterile packaging, posing a potential infection risk.

    Product
    Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2986-2018·2018-09-12

    GE Vivid E80 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling Vivid E80, E90, and E95 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.

    Product
    GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2983-2018·2018-09-12

    GE LOGIQ E9 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling 12,426 LOGIQ E9 ultrasound systems because the power cord side may break, exposing electrical conductors and creating a risk of electric shock.

    Product
    GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2985-2018·2018-09-12

    GE Vivid E9 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling 12,426 Vivid E9 ultrasound systems because the power cord may break and expose electrical conductors, posing a risk of electric shock.

    Product
    GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2981-2018·2018-09-12

    Alden Optical Recalls Zenlens Toric Contact Lenses Due to Labeling Errors

    Alden Optical is recalling 36 vials of Zenlens Toric-Gas Permeable Contact Lenses because the vials contained incorrect lenses for the prescriptions labeled on them.

    Product
    Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve +…
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2975-2018·2018-09-12

    Quasar Pure Rayz Light Therapy System Recalled for Uncleared Claims

    Quasar Bio-Tech is recalling 6,783 Pure Rayz Light Therapy Systems because the packaging and manuals make claims about collagen and elastin production that were not cleared by the FDA.

    Product
    Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2965-2018·2018-09-12

    Zimmer Biomet Recalls 2.5mm Orthopedic Pegs Due to Packaging Error

    Zimmer Biomet is recalling 2.5mm orthopedic pegs because a larger 22mm peg was found in the package. The error affects 25 units distributed to Japan and the Netherlands.

    Product
    Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2967-2018·2018-09-12

    Encore Medical Recalls Foundation Modular Femoral Stem for Lack of Clearance

    Encore Medical is recalling 12 units of the Foundation Modular Femoral Stem because the device lacks FDA clearance.

    Product
    Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2969-2018·2018-09-12

    Inspire II Implantable Pulse Generator Recalled for Incorrect Use-By Date

    Inspire Medical Systems is recalling 93 Inspire II Implantable Pulse Generators because the device registration labels contain an incorrect use-by date.

    Product
    Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2973-2018·2018-09-12

    Quasar Bio-Tech Recalls Baby Quasar Plus Light Therapy System

    Quasar Bio-Tech is recalling the Baby Quasar Plus Light Therapy System because it lacks FDA clearance for specific collagen and elastin claims.

    Product
    Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2974-2018·2018-09-12

    Quasar MD Plus Light Therapy System Recalled for Uncleared Claims

    Quasar Bio-Tech, Inc. is recalling the Quasar MD Plus Light Therapy System because the packaging and user manuals contain claims for collagen and elastin production that were not cleared by the FDA.

    Product
    Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide