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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6876–6900 of 27393

  • HighFDA (Devices)·Z-0050-2024·2023-11-01

    Pregnancy test strips recalled due to manufacturing documentation gaps

    Universal Meditech Inc. is recalling To Life hCG pregnancy test strips because the company is ceasing operations and cannot verify manufacturing compliance. The firm cannot provide documentation of manufacturing standards, storage conditions, or post-market safety monitoring.

    Product
    To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0181-2024·2023-11-01

    Pediatric Urology Equipment Recalled Due to Improper Sterilization

    American Contract Systems is recalling Pediatric Urology Wolson Packs due to components being exposed to unapproved sterilization processes. Components may have lost functionality or reduced efficacy, potentially compromising device performance.

    Product
    Pediatric Urology Wolson Pack, REF BPPU55A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2024·2023-11-01

    Smiths Medical Blood Sampling Kits Missing Critical Filter Component

    Smiths Medical is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits due to missing filter components. Kits without the filter can produce inaccurate test results or expose users to infectious blood.

    Product
    Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0049-2024·2023-11-01

    Pregnancy Test Recalled for Unverified Manufacturing Compliance and Firm Closure

    Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.

    Product
    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0048-2024·2023-11-01

    Pregnancy Test Cassettes Recalled for Unverified Performance and Authorization

    Universal Meditech Inc. is recalling DeTec hCG pregnancy test cassettes due to unverified marketing authorization and missing manufacturing documentation. Device performance characteristics cannot be confirmed.

    Product
    DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0139-2024·2023-11-01

    Centricity PACS-IW Medical Imaging System Mixed Patient Data

    Centricity PACS-IW medical imaging software versions may store images from two different patients within a single study, creating potential clinical confusion during diagnostic review.

    Product
    Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0127-2024·2023-11-01

    TruDi Navigation System position discrepancy during ENT surgery

    A surgical navigation system used in ENT procedures may display incorrect curette tip positions, potentially causing delayed surgery, cerebrospinal fluid leaks, vision loss, or skull damage. The recall affects 141 units across 30 US states.

    Product
    TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0177-2024·2023-11-01

    Cardiovascular Surgical Device Components Recalled for Improper Sterilization

    American Contract Systems recalls cardiovascular surgical device components that were subjected to improper ethylene oxide sterilization at excessive temperatures, potentially causing loss of functionality or drug efficacy.

    Product
    Vasc. Open CVOR SJH, REF SJVO56B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2024·2023-11-01

    OMTMO Ovulation Test Strips Recalled for Unverified Manufacturing Quality

    Universal Meditech Inc. is recalling 40,000 OMTMO ovulation test strips because the manufacturer is closing operations and cannot provide required manufacturing and quality documentation.

    Product
    OMTMO One Step Ovulation (LH) Test Strips REF 200-07
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0140-2024·2023-11-01

    Radiological imaging software may mix images from different patients

    GE Healthcare Centricity Universal Viewer software versions 6.0 SP0-SP7.1 may combine radiological images from different patients into a single study, potentially affecting patient care and diagnosis.

    Product
    Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0154-2024·2023-11-01

    Preat Neodent Healing Abutments Recalled for Dimensional Gap Risk

    Preat Corp is recalling Neodent dental healing abutments (REF 9007124) due to a dimensional condition that may cause gaps between the abutment and implant, potentially allowing microleakage.

    Product
    Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0157-2024·2023-11-01

    JOURNEY II Knee Prosthesis Components Incorrectly Labeled and Packaged

    Smith & Nephew recalled 28 JOURNEY II knee prosthesis inserts because two different articular types were mislabeled and swapped during packaging. The incorrect labeling prevents identification of the actual insert type.

    Product
    JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2024·2023-11-01

    Radiological imaging system may display wrong patient information in workflow

    GE Healthcare's Centricity Universal Viewer Workflow Manager may display exam information for a different patient when third-party reporting applications launch exams. The mismatch could lead to incorrect patient identification.

    Product
    Centricity Universal Viewer Workflow Manager, Image processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0047-2024·2023-11-01

    pH Test Strips Recalled for Unverified Manufacturing and Unknown Performance

    Universal Meditech Inc. is recalling HealthyWiser pH-Aware pH Test Strips because the manufacturer lacks documentation verifying manufacturing compliance and device performance. The company is ceasing operations and cannot fulfill post-market safety responsibilities.

    Product
    HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0057-2024·2023-11-01

    PrestiBio Urinalysis Test Strips Recalled for Unverified Manufacturing

    Universal Meditech Inc. is recalling PrestiBio URINALASYS TEST STRIP 10 PARAMETERS due to missing manufacturing documentation and unverified device performance. The manufacturer is ceasing operations and cannot demonstrate the devices meet quality standards.

    Product
    PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0182-2024·2023-11-01

    Cath Cardiac Pack sterilization failure may cause loss of functionality

    American Contract Systems recalled 1260 units of Cath Cardiac Pack due to improper sterilization exposure that may cause loss of functionality or higher ethylene oxide residuals.

    Product
    Cath Cardiac Pack, REF IHCC03V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2024·2023-11-01

    Medical device components subjected to improper sterilization process and elevated exposure

    American Contract Systems is recalling LAVH surgical component kits because two components were subjected to improper sterilization temperatures and ethylene oxide exposure, potentially causing loss of functionality and higher chemical residuals.

    Product
    LAVH, REF BBLV21C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2024·2023-11-01

    Knee prosthesis component mislabeled with swapped product identification

    Smith & Nephew is recalling 29 units of a knee prosthesis component due to labeling and packaging errors where two product types were swapped during manufacturing.

    Product
    JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2024·2023-11-01

    Robotics Pack Sterilization Error Affects IV Catheter and Adhesive Components

    American Contract Systems recalls Robotics Pack SAH components due to improper sterilization exposure. The IV catheter and adhesive components may lack functionality or contain excess sterilization residue.

    Product
    Robotics Pack SAH, REF SAR530M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2024·2023-11-01

    Omega Medical Imaging Monitor Suspension Systems Recalled for Boom Detachment Risk

    Omega Medical Imaging recalls monitor boom systems where the actuator can separate from the pivot mechanism, allowing the boom to detach. The defect affects units manufactured between October 2012 and July 2019.

    Product
    Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0155-2024·2023-11-01

    SOZO Bilateral Arm L-Dex Software inadequate lymphedema detection sensitivity

    Impedimed's SOZO Bilateral Arm L-Dex Software (versions 4.1 and 5.0) has inadequate sensitivity for detecting early lymphedema, which could delay treatment. The FDA is recalling 354 units distributed nationwide.

    Product
    SOZO Bilateral Arm L-Dex Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2024·2023-11-01

    Medical Device Packs Recalled for Improper Sterilization Process

    American Contract Systems recalled General Pack medical device components (I.V. catheters and adhesive) that were improperly sterilized with ethylene oxide at higher than approved temperatures. The components may lack functionality or have elevated sterilization residuals.

    Product
    General Pack, REF BBGP31C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2024·2023-11-01

    Robotics Pack I.V. Catheter and Adhesive Recalled for Sterilization Defect

    American Contract Systems is recalling its Robotics Pack (56 cases) due to improper sterilization of IV catheter and adhesive components. The devices may have lost functionality or drug efficacy and may contain excessive ethylene oxide residuals.

    Product
    Robotics Pack, REF SSRO22D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0152-2024·2023-11-01

    Preat Neodent Dental Healing Abutment Recalled for Dimensional Defect

    Preat Corp is recalling Preat REF 9007121 Neodent GM x 2mm Healing Abutments due to a dimensional condition that may create a gap between the abutment and implant, potentially allowing microleakage. Affected devices were distributed in multiple US states.

    Product
    Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
    Category
    Medical Device
    Distribution
    7 states