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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15701–15725 of 39988

  • HighFDA (Devices)·Z-0457-2021·2020-11-25

    Stryker Recalls Osteosynthesis Compression Staple EasyClip Devices

    Stryker GmbH is recalling EasyClip and EasyClip Xpress staples due to potential nickel release above safety margins in pediatric patients under 20 kg.

    Product
    Osteosynthesis Compression Staple EasyClip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2021·2020-11-25

    MeritMedical Cultura Flex Swab Recall Due to Tip Breakage Risk

    Merit Medical Systems is recalling Cultura Flex Swabs because the flocked tip may break off during use, potentially causing soft tissue injury or treatment delays.

    Product
    MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2021·2020-11-25

    Thomas Scientific Recalls Wuxi Nest Patient Specimen Collection Tubes

    Thomas Scientific is recalling Wuxi Nest patient specimen collection tubes to replace units manufactured and distributed prior to Enforcement Discretion Approval.

    Product
    Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2021·2020-11-25

    Mako MICS Handpiece Recalled for Potential Bone Preparation Discrepancies

    Stryker is recalling Mako MICS Handpieces due to a characterization issue that may cause unsuccessful checkpoint verification or bone cuts differing from the preoperative plan.

    Product
    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2021·2020-11-25

    Cardinal Health Recalls Kangaroo Connect 1000ml Bag Sets Due to Leak Risk

    Cardinal Health 200, LLC is recalling Kangaroo Connect 1000ml Bag Sets because the feeding spike sets may leak at the tube and spike connector interface.

    Product
    Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2021·2020-11-25

    GE v|tome|x L Series X-ray Systems Recalled for Warning Signal Defect

    GE Inspection Technologies is recalling v|tome|x L Series X-ray systems because pre-warning signals may fail to activate if the warm-up mode is not completed.

    Product
    v|tome|x L Series non-destructive testing cabinet x-ray systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0455-2021·2020-11-25

    Merit Medical Cultura Collection and Transport System recall due to swab tip breakage risk

    Merit Medical recalls its Cultura Collection and Transport System because the swab tip may break off during sample collection, potentially causing soft tissue injury.

    Product
    Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2021·2020-11-25

    Roche Recalls cobas infinity Software Due to Incorrect Validation

    Roche Diagnostics is recalling 40 cobas infinity central lab licenses because an erroneous QC status may cause incorrect validation of results.

    Product
    cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2021·2020-11-25

    Merit Medical Cultura Collection and Transport System Swab Tip Breakage Recall

    Merit Medical is recalling Cultura Collection and Transport Systems because the swab tip may break off during sample collection, potentially causing soft tissue injury.

    Product
    Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2021·2020-11-25

    Medicrea Ligapass Tension Pulley Handle Recalled for Band Breakage Risk

    Medicrea International is recalling Ligapass Tension Pulley Handles because the instrument can crush the band, causing it to break during surgery and leading to infection risk.

    Product
    MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0473-2021·2020-11-25

    Siemens Atellica IM 1300 Analyzer Recalled for Test Definition Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers because scanning specific test definitions may reset custom settings, causing inaccurate test results.

    Product
    Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0451-2021·2020-11-25

    Ortho Recalls VITROS Anti-SARS-CoV-2 IgG Control Due to Signal Issues

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Control and Calibrator lots due to elevated signal/cutoff values and decreased signal.

    Product
    VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0462-2021·2020-11-25

    LivaNova VNS Therapy AspireSR Generator Recall for Serial Number Error

    LivaNova is recalling 134 VNS Therapy AspireSR Generators because an extra digit in the serial number makes them incompatible with specific therapy programmers.

    Product
    VNS Therapy¿ AspireSR¿ Generator
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0469-2021·2020-11-25

    Siemens Artis X-Ray Systems Recalled for Overvoltage Protection Defect

    Siemens is recalling 26 Artis X-ray systems worldwide because incorrect diodes may fail to protect against overvoltage, potentially causing system malfunction.

    Product
    Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0468-2021·2020-11-25

    Strauss 25 Carbide Dental Burs Recalled for Incorrect Packaging

    Coltene Whaledent Inc is recalling Strauss 25 Carbide Dental Burs because they were incorrectly packaged as a different model, posing a risk of excessive material removal.

    Product
    Strauss 25 Carbide Dental Burs (100057XXV)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0459-2021·2020-11-25

    Exactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling

    Exactech, Inc. is recalling 69 Equinoxe Cage Glenoid, Posterior Augment, Left, Medium devices because they may be mislabeled.

    Product
    Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-0474-2021·2020-11-25

    Siemens Atellica IM 1600 Analyzer Recalled for Custom Settings Reset

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers because scanning a new kit lot may reset custom settings to defaults.

    Product
    Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2021·2020-11-25

    Ortho Recalls VITROS SARS-CoV-2 IgG Calibrators Due to Elevated Signal Values

    Ortho Clinical Diagnostics is recalling specific lots of VITROS SARS-CoV-2 IgG Calibrators because they produced elevated signal values. The recall also includes one lot of IgG Controls with decreased signal.

    Product
    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0440-2021·2020-11-25

    Inova Lasers Recalls Class IV New Era Medical Laser Devices

    Inova Lasers LLC is recalling eight Class IV New Era medical laser devices because they failed to comply with Electronic Product Radiation Control regulations.

    Product
    Class IV New Era medical laser device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0460-2021·2020-11-25

    Exactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling

    Exactech is recalling 40 Equinoxe Cage Glenoid, Posterior Augment, Right, Medium devices due to potential mislabeling. The devices were distributed to US and international consignees.

    Product
    Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
    Category
    Medical Device
    Distribution
    21 states
  • LowFDA (Devices)·Z-0458-2021·2020-11-25

    Steris Olympus Leak Test Adapter Recalled for Cleaning Solution Intrusion Risk

    Steris Corporation is recalling Olympus Leak Test Adapters used with Acu-sInQ systems due to a potential for cleaning solution to intrude into endoscopes.

    Product
    Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
    Category
    Medical Device
    Distribution
    Distributed nationwide