The Recall Desk

State

American Samoa product recalls

73,100 recalls have nationwide distribution and so reach American Samoa. 25 additional recalls listed American Samoa specifically in their distribution scope.

What the numbers show

Total
25
Critical
1
Severe
5
Most recent
2026-09-09

Of the 25 recalls naming American Samoa we have scored against our rubric, 1 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (20%) are Severe.

Which agencies issued them

These figures cover only the 25 recalls whose distribution notice names American Samoa specifically. The 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

11601–11625 of 73125

  • SevereFDA (Devices)·Z-1500-2024·2024-04-24

    Philips Garbin EVO Ventilator False Battery Alarm Causes Ventilation Loss

    Philips Respironics recalls 1,233 Garbin EVO ventilators. A software defect in the battery and power alarm system may cause sudden loss of ventilation despite adequate power supply.

    Product
    Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1503-2024·2024-04-24

    Trilogy Evo O2 Ventilator Recalled for Potential Sudden Loss of Ventilation

    Philips Respironics is recalling 789 Trilogy Evo O2 ventilators due to a software defect that can trigger a false power alarm despite sufficient power, potentially causing sudden loss of ventilation in pediatric and adult patients.

    Product
    Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1504-2024·2024-04-24

    Trilogy Evo Ventilator Recall Due to Potential Loss of Ventilation

    Philips Respironics is recalling the Trilogy Evo ventilator (76,713 units) because it may suddenly stop ventilating when a false Battery Depleted or Loss of Power alarm triggers despite sufficient power available.

    Product
    Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1499-2024·2024-04-24

    Philips Respironics Aeris EVO Ventilators Recalled for Loss of Ventilation Risk

    Philips Respironics is recalling Aeris EVO ventilators due to a software defect that may cause false battery or power alarms while the device retains adequate power, risking sudden loss of ventilation in pediatric and adult patients. Approximately 775 units are affected.

    Product
    Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1502-2024·2024-04-24

    Philips Trilogy EV300 Ventilator False Power Alarm Defect Recall

    Philips is recalling 56,012 Trilogy EV300 ventilators due to a software defect that can trigger a false Battery Depleted or Loss of Power alarm despite adequate power, risking sudden loss of ventilation.

    Product
    Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1529-2024·2024-04-24

    Gastrointestinal Suture Anchor Recalled Due to Packaging Seal Defect

    Cook Incorporated is recalling the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set due to packaging that may have insufficient seal strength, potentially compromising device sterility. The recalled lot is distributed worldwide.

    Product
    Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1525-2024·2024-04-24

    Chiba Biopsy Needles Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling Chiba Biopsy Needles due to packaging that may have low seal strength, potentially compromising device sterility. The recall affects 6,178 units distributed worldwide.

    Product
    Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2024·2024-04-24

    Marketing brochures for Baxter surgical vessel occluders contain inaccurate information

    Baxter Healthcare is recalling marketing brochures for surgical vessel occluders and related devices because the brochures contain information that does not match the official product instructions for use.

    Product
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2024·2024-04-24

    Surgical and Cardiovascular Device Marketing Brochures Recalled for Documentation Errors

    Baxter Healthcare is recalling surgical and cardiovascular device marketing brochures that contain information conflicting with the official Instructions for Use. The inaccurate content could lead to incorrect device use.

    Product
    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2024·2024-04-24

    Philips Intera 1.5T MRI System Patient Support Table Installation Defect

    Philips is recalling certain Intera 1.5T MRI systems because the patient support table floor plate may be incorrectly installed, which could affect patient safety.

    Product
    Intera 1.5T Omni/Stellar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2024·2024-04-24

    Philips Achieva 1.5T MRI Systems Recalled Due to Incorrect Support Table Installation

    Philips is recalling 1,921 Achieva 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.

    Product
    Achieva 1.5T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2024·2024-04-24

    Philips Intera 0.5T MRI System Patient Table Floor Plate Installation Defect

    Philips is recalling 14 Intera 0.5T MRI systems due to potential misinstallation of the patient support table floor plate, which could affect equipment stability and patient safety.

    Product
    Intera 0.5T Standard, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2024·2024-04-24

    Philips MRI System Patient Support Table Installation Defect Recall

    Philips recalls 25 Intera 1.5T R11 MRI systems due to potential incorrect installation of the patient support table floor plate, which may affect patient safety during device operation.

    Product
    Intera 1.5T R11, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2024·2024-04-24

    Philips Intera 1.5T MRI Patient Support Table Floor Plate Installation Defect

    Philips is recalling 46 units of the Intera 1.5T Achieva Nova MRI system due to improper installation of the patient support table floor plate. The defect may compromise patient safety during use.

    Product
    Intera 1.5T Achieva Nova, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2024·2024-04-24

    MRI Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.

    Product
    GYROSCAN T5-NT, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2024·2024-04-24

    Fetal Membrane Rupture Test Kits Recalled for False Positive Results

    Actim PROM dipstik fetal membrane rupture test kits are recalled because personal lubricants can interfere with the test, producing false positive results.

    Product
    Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1544-2024·2024-04-24

    Neria Soft Infusion Sets recalled due to incorrect instruction manual

    Unomedical A/S is recalling 10,770 units of Neria Soft Infusion Sets because certain lots were shipped with incorrect instructions for use. The wrong instruction manual for Rest of World markets was included instead of the FDA-approved US version.

    Product
    Neria Soft Infusion Set, Product Code 507302, intravascular administration set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2024·2024-04-24

    Philips MRI patient support table floor plate installation defect recall

    Philips is recalling 107 Intera 1.5T MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create safety risks during patient use.

    Product
    Intera 1.5T Master/Nova, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2024·2024-04-24

    Siemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results

    Siemens Atellica CH and CI analyzers may produce falsely elevated cholesterol and lipid test results (2–16% high) after iron tests. This affects clinical calibration, quality control checks, and patient test results.

    Product
    Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer Siemens Material Number (SMN): 11537211
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2024·2024-04-24

    Philips MRI System Patient Support Table Floor Plate Installation Issue

    Philips is recalling 9 Intera 3.0T Quasar Dual MRI systems (Model 781150) distributed worldwide. The patient support table floor plate may be incorrectly installed on these units.

    Product
    Intera 3.0T Quasar Dual, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2024·2024-04-24

    Ingenia 3.0T magnetic resonance system patient support floor plate installation defect

    Philips is recalling Ingenia 3.0T MRI systems due to incorrect patient support table floor plate installation. Affected healthcare facilities should verify installation status and contact Philips for corrective action.

    Product
    Ingenia 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2024·2024-04-24

    MRI system patient support table floor plate installation defect

    Philips MRI systems may have an incorrectly installed patient support table floor plate, creating a potential stability risk during patient imaging.

    Product
    SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2024·2024-04-24

    MRI System Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips North America is recalling 7 GYROSCAN T5 MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create a safety risk during patient table use.

    Product
    GYROSCAN T5, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide