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.

11651–11675 of 73125

  • HighFDA (Devices)·Z-1530-2024·2024-04-24

    Cook Incorporated Dilators Recalled for Low Packaging Seal Strength

    Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.

    Product
    Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6
    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-1536-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter Recall: Potential Automatic Power Loss

    Masimo Corporation is recalling 443 Rad-G pulse oximeters that may automatically power off and on, interrupting patient monitoring. Affected units are distributed worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
    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-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-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 (Drugs)·D-0445-2024·2024-04-24

    Eli Lilly Recalls Humalog Sterile Diluent Due to Manufacturing Deviations

    Eli Lilly & Company has voluntarily recalled 700 vials of Humalog sterile diluent due to Current Good Manufacturing Practice (CGMP) deviations. The affected batch (D608951C, exp. 4/10/2025) was distributed nationwide.

    Product
    HUMALOG — HUMALOG (INSULIN LISPRO)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2024·2024-04-24

    MRI Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips is recalling 24 units of the Intera Achieva 1.5T Pulsar MRI System because the patient support table floor plate may be incorrectly installed. Worldwide distribution affected.

    Product
    Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1559-2024·2024-04-24

    MRI System Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips has recalled 50 units of its GYROSCAN ACS-NT MRI systems. The patient support table floor plate may be incorrectly installed, potentially posing a safety risk.

    Product
    GYROSCAN ACS-NT, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter Recall: Risk of Automatic Power Loss

    Masimo Corporation is recalling 65 Masimo Rad-G pulse oximeters due to a potential defect causing automatic power cycling that could result in loss of patient monitoring.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2024·2024-04-24

    Philips Ingenia MRI System Patient Support Table Floor Plate Installation Defect

    Philips is recalling 135 Ingenia 1.5T S MRI systems worldwide because the patient support table floor plate may be incorrectly installed, creating a potential safety risk to patients and staff.

    Product
    Ingenia 1.5T S, Magnetic Resonance System.
    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-1545-2024·2024-04-24

    CryoValve SG Heart Valve Recalled for Staphylococcus aureus Contamination

    Artivion is recalling one CryoValve SG cryopreserved heart valve contaminated with Staphylococcus aureus, detected during organ donation screening. No illnesses have been reported.

    Product
    CryoValve SG Cryopreserved Pulmonary Human Heart Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2024·2024-04-24

    MRI System Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips Intera CV MRI systems may have an incorrectly installed patient support table floor plate. Eight units have been recalled due to this installation defect.

    Product
    Intera CV, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1574-2024·2024-04-24

    MRI patient support table floor plate may be incorrectly installed

    Philips Intera 1.0T MRI systems may have patient support table floor plates that are incorrectly installed. The defect poses a potential safety risk to patients. Facilities should verify installation and contact Philips service personnel for inspection.

    Product
    Intera 1.0T Power/Pulsar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2024·2024-04-24

    Cook Coons Taper Dilators recalled due to low packaging seal strength

    Cook Incorporated is recalling 4,856 Coons Taper Dilators because packaging may have low seal strength, compromising device sterility. These percutaneous dilators are used in vascular and non-vascular procedures and are distributed worldwide.

    Product
    Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2024·2024-04-24

    Philips Achieva 3.0T MRI System Patient Support Table Floor Plate Installation Defect

    Philips has recalled 511 units of the Achieva 3.0T Magnetic Resonance System due to a potential installation defect in the patient support table floor plate, which could affect table stability and patient safety.

    Product
    Achieva 3.0T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2024·2024-04-24

    Masimo Rad-G Pulse Oximeter May Randomly Power Off, Causing Loss of Monitoring

    Approximately 21,723 Masimo Rad-G pulse oximeters may randomly power off and on, causing temporary loss of patient monitoring. The FDA classified this as a Class II recall affecting devices distributed worldwide.

    Product
    Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2024·2024-04-24

    SW Bari Lift & Transfer Device Recalled Due to Weight and Safety Defects

    Raye's Inc. is recalling the SW Bari Lift & Transfer (Model 38060000) due to two critical defects: it cannot safely support its maximum rated weight, and it lacks a safety mechanism to prevent falls during a single equipment failure.

    Product
    SW Bari Lift & Transfer, Model Number 38060000
    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
  • HighFDA (Devices)·Z-1591-2024·2024-04-24

    Conformis Identity Imprint PS Tibial Tray Size 4 Packaging Error

    Conformis is recalling Identity Imprint PS Tibial Tray Size 4 implants due to a packaging error where Size 5 components were placed in Size 4 boxes with incorrect lot numbers.

    Product
    Identity Imprint PS Tibial Tray Size 4: Lot 540287
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2024·2024-04-24

    Baxter surgical tool marketing brochures contain inaccurate Instructions for Use

    Baxter Healthcare Corporation recalled marketing brochures for surgical tools that contain inaccurate information conflicting with the product Instructions for Use. Over 82,000 units were distributed worldwide.

    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: Vascular Probe, Item Numbers: a) 708101
    Category
    Medical Device
    Distribution
    Distributed nationwide