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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16476–16500 of 89775

  • HighFDA (Devices)·Z-0064-2024·2023-11-01

    FDA Recalls Pregnancy Test Cassettes Due to Unverified Manufacturing

    Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.

    Product
    DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
    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-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-0166-2024·2023-11-01

    Grafton Plus DBM Paste medical device recalled for packaging inspection failure

    Medtronic is recalling Grafton Plus DBM Paste due to a missed inspection step on the outer packaging. The outer Tyvek pouch may have non-conformances that could affect product integrity.

    Product
    Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
    Category
    Medical Device
    Distribution
    0 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
  • 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 (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-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-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 (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-0161-2024·2023-11-01

    Medtronic Grafton DBM Crunch surgical implant packaging inspection defect

    Medtronic is recalling Grafton DBM Crunch bone matrix surgical implants due to potential packaging defects in the outer Tyvek pouch. An inspection step may not have been completed according to requirements.

    Product
    Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0058-2024·2023-11-01

    FDA Recalls Ovulation Test Strips for Unverified Manufacturing and Documentation

    FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.

    Product
    DiagnosUS One Step LH Ovulation Test Strip REF 200-07
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0303-2024·2023-11-01

    Penzeys Brady Street Cheese Sprinkle recalled for undeclared sesame allergen

    Penzeys, Ltd. is recalling Brady Street Cheese Sprinkle because it may contain sesame, which is not declared on the label. People with sesame allergies should not consume this product.

    Product
    Penzeys Brady Street Cheese Sprinkle. Item 20756. net wt 2.2 oz (62g). Penzeys Spices, Wauwatosa, WI 53222.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2024·2023-11-01

    Grafton DBM Orthoblend Recall Due to Sterile Packaging Inspection Issue

    Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Orthoblend, an orthopedic implant material, because a required sterile packaging inspection step may not have been performed according to specifications.

    Product
    Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0126-2024·2023-11-01

    SynCardia Artificial Hearts Recalled for Unapproved Epoxy Resin

    SynCardia Systems is recalling 114 units of the SynCardia 50cc TAH-t artificial heart because it contains an epoxy resin that has not been reviewed by the FDA for safety and efficacy.

    Product
    SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0042-2024·2023-11-01

    One Step Pregnancy Test Recalled for Unverified FDA Marketing Authorization

    Universal Meditech recalled 147,000 pregnancy tests lacking verified FDA clearance and quality documentation. The manufacturer is closing and cannot support post-market safety surveillance.

    Product
    One Step Pregnancy Test REF 100-01
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0153-2024·2023-11-01

    Preat Neodent Healing Abutment Recalled Due to Dimensional Defect

    Preat Corp is recalling 23 Neodent GM x 4mm Healing Abutments due to a dimensional defect that may allow microleakage between the abutment and implant. Affected units were distributed to dental practices in multiple US states.

    Product
    Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
    Category
    Medical Device
    Distribution
    7 states
  • 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-0051-2024·2023-11-01

    PrestiBio Breast Milk Alcohol Test Strips Recalled for Lack of Marketing Authorization

    Universal Meditech Inc. is recalling PrestiBio Breast Milk Alcohol Test Strips because the company distributed them without FDA marketing authorization and cannot verify they were manufactured properly. The firm is ceasing operations and cannot fulfill post-market responsibilities.

    Product
    PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0156-2024·2023-11-01

    Omega Medical Imaging Monitor Suspension Actuator Separation Risk

    Omega Medical Imaging is recalling 52 monitor suspension systems (Part Number 1000-0085) manufactured 2012–2019 in which the actuator may separate from the pivot mechanism. An installed safety cable contained one such failure, but the structural issue poses a falling hazard. No injuries reported.

    Product
    Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
    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-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
  • HighNHTSA·23V733000·2023-11-01

    Mercedes-Benz Recalls 2020 GLS 580 for Sunroof Software Error

    Mercedes-Benz is recalling 2020 GLS 580 vehicles because a software error may cause the sunroof to close unexpectedly, increasing the risk of injury.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLS 580 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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