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.

Filters

Agency

Category

Minimum severity

Clear filters

13676–13700 of 13802

  • HighFDA (Devices)·Z-1799-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate System screw failure recalled

    Alphatec is recalling its Insignia Anterior Cervical Plate System due to potential screw blocking mechanism failure during or after spinal surgery. The screw may disassociate intraoperatively or unlock postoperatively.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2021·2021-06-16

    Anterior Cervical Plate System Screw Blocking Mechanism May Disassociate

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism. The screws may disassociate or unlock during or after surgery, risking implant failure.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1800-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System screw mechanism failure

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate or unlock during or after spine surgery, potentially compromising implant stability.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1845-2021·2021-06-16

    DePuy Synthes Hip Prosthesis Recall Due to Incorrect Size Labeling

    DePuy Orthopaedics recalled 50 hip prostheses with incorrect part numbers and sizes etched on the devices. The affected Lot D20111130 was distributed domestically and to Bermuda.

    Product
    DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1841-2021·2021-06-16

    Medline Tissue Recovery Instrument Sets Recalled for Sterility Assurance Failure

    Medline Industries is recalling Tissue Recovery Instrument Sets due to failure to meet sterility assurance levels. The instruments, used for tissue recovery in medical research and transplantation, were distributed in Wisconsin.

    Product
    Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1826-2021·2021-06-16

    Atec Insignia Cervical Plate Screw Locking Mechanism May Fail

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism that could cause separation during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2021·2021-06-16

    WishBone Medical Plate and Screw System Engineering Specification Nonconformity Recall

    Wishbone Medical is recalling WishBone Medical Plate and Screw System implants due to nonconformities in engineering specifications. The recall affects 60 units distributed in Virginia, Pennsylvania, and Indiana.

    Product
    WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1819-2021·2021-06-16

    Anterior Cervical Plate System Recalled for Screw Locking Failure

    Alphatec Spine is recalling its Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism during or after surgery that could compromise implant stability.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2021·2021-06-16

    Sunstar G.U.M Perioshield Oral Rinse Recalled Due to Bacterial Contamination

    Sunstar Americas is recalling SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse 300mL (SKU 1775P, 1775R) due to potential contamination with Burkholderia bacteria.

    Product
    SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2021·2021-06-16

    Quanta System Sterile Optical Laser Fiber Recall for Potential Sterility Compromise

    Quanta System is recalling 307 reusable sterile optical laser fibers nationwide due to potential sterility compromise. The affected devices were distributed through six U.S. distributors.

    Product
    Quanta System Sterile Optical Laser Fiber, reusable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Recall: Potential Screw Mechanism Failure

    Alphatec Spine is recalling 7 units of the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2021·2021-06-16

    Cervical Plate System screw locking mechanism may fail during or after surgery

    Alphatec Insignia Anterior Cervical Plate System screw blocking mechanism may disassociate during surgery or unlock afterward. No injuries reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate Screw Blocking Mechanism Disassociation Recall

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw blocking mechanism that may disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System recall due to potential screw mechanism failure

    Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1831-2021·2021-06-16

    Laboratory Software Device May Produce Erroneous Results from Inadequate Instructions

    Normand Remisol Advance Data Manager versions 1.5–1.9 have insufficient instructions for proper rule programming and testing. User-written rules may not be properly validated, potentially leading to erroneous laboratory results.

    Product
    Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism May Fail Intraoperatively

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2021·2021-06-16

    Diagnostic MR imaging system hoisting blocks mechanical defect

    Philips is recalling 156 Ingenia Ambition S diagnostic MR systems due to a mechanical issue detected in the lifting blocks on the magnet used during equipment movement and decommissioning.

    Product
    Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1830-2021·2021-06-16

    VIA Microcatheter shipped with incorrect international labeling instead of US labels

    MICROVENTION INC. is recalling VIA Microcatheter units that were inadvertently shipped with international labeling instead of US-cleared labeling. Units were distributed in six U.S. states.

    Product
    VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1835-2021·2021-06-16

    Medical microscope slide stainer recalled due to defective pump tubing

    Hardy Diagnostics is recalling the Quickslide GramPro 1 Automated Gram Stanier due to defective tubing in the pump mechanism that could cause device malfunction.

    Product
    Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2021·2021-06-16

    VIA Microcatheter VIA 21 Recalled for International Labeling Error

    MICROVENTION INC. is recalling VIA Microcatheter VIA 21 units (Lot 19110403M) because they were shipped with international labeling instead of FDA-cleared US labeling.

    Product
    VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1828-2021·2021-06-16

    VIA Microcatheter recalled due to incorrect international labeling shipped to US

    MicroVention is recalling certain VIA Microcatheter units that were shipped with international labeling instead of US-approved labeling. Affected units were distributed across six US states.

    Product
    VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1651-2021·2021-06-09

    Alaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk

    FDA recalls 22 serviced Alaris Model 8100 infusion pump units with bezel components that may crack or separate, risking free flow, over-infusion, under-infusion, or treatment interruption. Units distributed to Indiana and Texas between September 2020 and February 2021.

    Product
    Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1620-2021·2021-06-09

    Leccurate SARS-CoV-2 Antigen Test Kit Recalled: Not FDA-Approved for U.S. Distribution

    The Leccurate SARS-CoV-2 Antigen Rapid Test Kit is being recalled because it was not authorized, cleared, or approved for marketing in the United States. Approximately 8.4 million units were distributed worldwide, including to U.S. states and territories.

    Product
    Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1619-2021·2021-06-09

    Leccurate COVID-19 Antibody Test Kit Recalled for Unauthorized U.S. Distribution

    LEPU Medical has recalled the Leccurate SARS-CoV-2 Antibody Rapid Test Kit because it is not authorized, cleared, or approved for marketing in the U.S. Approximately 8.4 million units have been distributed worldwide.

    Product
    Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adapti
    Category
    Medical Device
    Distribution
    4 states