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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15751–15775 of 27769

  • SevereFDA (Devices)·Z-0148-2024·2023-11-01

    Monoject 20 mL Syringes Recalled for Infusion Pump Compatibility Issues

    Cardinal Health is recalling 4.9 million Monoject 20 mL Luer-Lock syringes due to compatibility and recognition issues with infusion pumps. Affected lot numbers from 2022 and 2023 were distributed nationwide.

    Product
    Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
    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-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-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-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-0067-2024·2023-11-01

    DiagnosUS Ovulation Predictor test recalled due to unverified manufacturing documentation

    Universal Meditech Inc. is recalling DiagnosUS Ovulation Predictor Midstream devices due to lack of FDA marketing authorization and inability to verify manufacturing compliance. The manufacturer is ceasing operations.

    Product
    DiagnosUS Ovulation Predictor Midstream REF 200-17
    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-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-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-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-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-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-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-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-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-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 (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 (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-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-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-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