The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

14376–14400 of 27206

  • 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-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-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-0055-2024·2023-11-01

    Pregnancy Test Kits Recalled Due to Unverified Manufacturing and Unauthorized Distribution

    Universal Meditech Inc. is recalling PrestiBio Rapid Detection Pregnancy Test Midstream kits (manufactured after March 2021) because the company distributed them without FDA authorization and cannot verify manufacturing compliance.

    Product
    PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0065-2024·2023-11-01

    Pregnancy Test Cassettes Recalled for Unknown Performance Characteristics

    Universal Meditech Inc. recalls DiagnosUS hCG Pregnancy Test cassettes distributed in eight U.S. states due to lack of manufacturing documentation and unknown performance characteristics. The firm is going out of business.

    Product
    DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
    Category
    Medical Device
    Distribution
    8 states
  • 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-0056-2024·2023-11-01

    Ketone Test Strips Recalled for Lack of FDA Marketing Authorization

    Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.

    Product
    PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Drugs)·D-0068-2024·2023-11-01

    ION Sinus Support Nasal Spray Recalled for Microbial Contamination

    Biomic Sciences is recalling all lots of ION Sinus Support Nasal Spray due to microbial contamination. The product has been distributed nationwide and internationally.

    Product
    ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-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-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-0176-2024·2023-11-01

    Pediatric Heart SJH Device Recall Due to Improper Sterilization

    American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.

    Product
    Pediatric Heart SJH, REF SJPH34K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • HighFDA (Devices)·Z-0137-2024·2023-11-01

    Maquet Acrobat-i Cardiac Stabilizer Jaw May Break During Surgery

    The Maquet Acrobat-i Vacuum Stabilizer System's housing mount jaw may break during cardiac surgery, risking injury to heart tissue, blood vessels, or bypass grafts.

    Product
    Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2024·2023-11-01

    Medical imaging system may display wrong patient information

    GE Healthcare's Universal Viewer Workflow Manager medical imaging software may show the wrong patient's information when third-party reporting applications are used. This data mismatch could cause confusion during medical procedures.

    Product
    Universal Viewer Workflow Manager, Image processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0069-2024·2023-11-01

    Restore Sinus Spray Recalled for Microbial Contamination

    Biomic Sciences is recalling Restore Sinus Spray due to microbial contamination of the non-sterile product. The product is distributed nationwide and internationally.

    Product
    Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2024·2023-11-01

    Surgical Microscope Suspension Arm May Fail Due to Missing Screw

    Carl Zeiss OPMI LUMERA 300 surgical microscopes may have a missing screw on the suspension arm, potentially allowing suspended components to fall and injure nearby persons. Eight units distributed in Maryland, Texas, California, Georgia, and Louisiana are affected.

    Product
    OPMI LUMERA 300, REF 6137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2024·2023-11-01

    UTI Test Strips Recalled for Lack of Quality Documentation and Compliance Verification

    Universal Meditech Inc. is recalling HealthyWiser UriTest™ UTI Test Strips due to missing documentation of Quality System compliance. The manufacturer is going out of business and cannot fulfill post-market safety obligations.

    Product
    HealthyWiser UriTest" UTI Test Strips REF 900-UTI
    Category
    Medical Device
    Distribution
    8 states
  • 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
    0 states
  • HighFDA (Devices)·Z-0066-2024·2023-11-01

    Pregnancy Test Recalled Due to Quality Documentation Issues and Unauthorized Distribution

    Universal Meditech Inc. is recalling DiagnosUS Pregnancy Test Midstream kits (3,304 units) due to inability to verify marketing authorization and missing quality documentation. The company, which is closing, cannot fulfill post-market safety responsibilities.

    Product
    DiagnosUS Pregnancy Test Midstream REF 100-17
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0062-2024·2023-11-01

    Universal Meditech diagnostic test strips recalled for unauthorized distribution

    Universal Meditech is recalling multiple diagnostic test strips distributed without FDA authorization. The company is closing and cannot provide documentation of manufacturing quality or post-market monitoring.

    Product
    Lem Fertility LH Ovulation Test (Strip) REF 200-07
    Category
    Medical Device
    Distribution
    8 states
  • 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