The Recall Desk

State

American Samoa product recalls

73,833 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
9
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 9 (36%) are Severe.

Which agencies issued them

These figures cover only the 25 recalls whose distribution notice names American Samoa specifically. The 73,833 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

51201–51225 of 73858

  • HighFDA (Devices)·Z-0218-2016·2015-11-11

    Brainlab Patient Data Manager Software Recalled for Image Display Errors

    Brainlab AG is recalling Patient Data Manager software versions 2.0.0 through 2.1.0 because objects may display incorrectly when users deselect fused reference datasets.

    Product
    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2016·2015-11-11

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Reboot Issues

    Philips is recalling HeartStart MRx monitor/defibrillators because they may reboot unexpectedly, interrupting or delaying therapy.

    Product
    HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2016·2015-11-11

    Otto Bock Triton Smart Ankle Recalled Due to Software Issue

    Otto Bock is recalling the Triton Smart Ankle and iOS Galileo app due to a software issue that can cause unexpected foot movement, posing a fall risk.

    Product
    iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2016·2015-11-11

    CareFusion Recalls SmartSite Extension Sets Due to Disconnection and Leakage

    CareFusion is recalling SmartSite Extension Sets because they may disconnect or leak. The recall affects 21,000 units distributed in the US and Canada.

    Product
    SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2016·2015-11-11

    GE Healthcare Recalls Centricity Universal Viewer Due to Inaccurate X-ray Measurements

    GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher because magnified projection X-ray images may display inaccurate distance measurements.

    Product
    The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0225-2016·2015-11-11

    GE Healthcare Recalls Centricity PACS-IW Due to Inaccurate X-Ray Measurements

    GE Healthcare is recalling Centricity PACS-IW software because it may display inaccurate distance measurements for magnified projection X-ray images.

    Product
    The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2016·2015-11-11

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Capacitor Degradation

    Philips is recalling 1,553 HeartStart MRx Monitor/Defibrillators because automated tests may degrade capacitors and the low battery indicator may fail.

    Product
    Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0163-2016·2015-11-11

    Valeant Recalls Fenoglide Tablets Due to Failed Dissolution Testing

    Valeant Pharmaceuticals is recalling specific bottles of Fenoglide (fenofibrate) 120 mg tablets because they failed 24-month dissolution testing.

    Product
    Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0213-2016·2015-11-11

    Ivoclar Recalls Helioseal F Dental Sealant Due to Production Defect

    Ivoclar A. G. is recalling specific lots of Helioseal F dental sealant because a production defect caused particles to be larger than defined, resulting in difficulties during extrusion.

    Product
    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0216-2016·2015-11-11

    ELITech Clinical Systems reagents recalled for potential drug interference

    ELITech Clinical Systems is recalling specific reagents used on Selectra ProS and ProM systems due to potential drug interference. No complaints have been received.

    Product
    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0231-2016·2015-11-11

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly where user-modified parameters revert to default values during ADD installation.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0214-2016·2015-11-11

    ELITech Eon 100 Reagents Recalled for Potential Drug Interference

    ELITech Clinical Systems is recalling Eon 100 reagents due to potential drug interference. No complaints have been received.

    Product
    Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0220-2016·2015-11-11

    Dako EnVision FLEX Visualization Reagent Recalled for Staining Defect

    Dako North America Inc. is recalling specific lots of EnVision FLEX visualization reagent kits due to a buffer defect causing non-specific background staining that interferes with result interpretation.

    Product
    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2016·2015-11-11

    Stryker UniVise Spinous Process Fixation Plate System Inserter Recalled

    Stryker Spine is recalling 41 units of the UniVise Spinous Process Fixation Plate System Inserter because the inner shaft does not fit through the device.

    Product
    Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0215-2016·2015-11-11

    ELITech Eon 300 Reagents Recalled for Potential Drug Interference

    ELITech Clinical Systems is recalling Eon 300 reagents due to potential drug interference. No complaints have been received.

    Product
    Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0217-2016·2015-11-11

    ELITech Envoy 500 Reagent Kits Recalled for Potential Drug Interference

    ELITech Clinical Systems is recalling Envoy 500 reagent kits due to potential drug interference. No complaints have been received.

    Product
    Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0206-2016·2015-11-11

    Bausch + Lomb Recalls Biotrue ONEday Lenses Due to Surface Defects

    Bausch + Lomb is recalling Biotrue ONEday contact lenses because a manufacturing defect on the lens surface may cause visual disturbances like halos or poor vision.

    Product
    BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0162-2016·2015-11-11

    Qualitest Recalls Ranitidine Syrup Due to Preservative Stability Failure

    Vintage Pharmaceuticals is recalling specific lots of Ranitidine Syrup because preservative levels failed stability specifications.

    Product
    RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0210-2016·2015-11-11

    Steris Recalls AMSCO Steam Sterilizers Due to Foot Pedal Software Issue

    Steris Corporation is recalling 32 AMSCO 400 and AMSCO C Small Steam Sterilizers because a software defect prevents the foot pedal from operating the door.

    Product
    AMSCO 400 and AMSCO C Small Steam Sterilizers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0202-2016·2015-11-11

    Ortho-Clinical VITROS Calibrator Kit 9 Recall for Wash Errors

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 9, Lot 0954, due to an increase in wash error condition codes.

    Product
    VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0198-2016·2015-11-11

    C.R. Bard Recalls Antibacterial Hydro Personal Catheters Due to Labeling Error

    C.R. Bard is recalling 4,170 units of Antibacterial Hydro Personal Catheters because the unit label may incorrectly state the product code and size.

    Product
    Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V743000·2015-11-10

    Van Hool Recalls 2015-2016 Motorcoaches Due to Air Brake Defect

    Van Hool is recalling 48 model year 2015-2016 TD925 and TDX25 motorcoaches because air brakes may take too long to release, potentially causing brake drag, heat buildup, or fire.

    Product
    VAN HOOL — VAN HOOL TD925, TDX25
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V744000·2015-11-10

    Maserati Recalls 2016 GranTurismo Vehicles Due to Door Latch Defect

    Maserati is recalling 135 model year 2016 GranTurismo vehicles because passenger side door latches may not be heat treated, increasing injury risk in a crash.

    Product
    MASERATI — MASERATI GRANTURISMO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V746000·2015-11-10

    Spartan MetroStar and Defense Chassis Cabs Recalled for Axle Nut Issue

    Spartan Motors is recalling 2014-2015 MetroStar and Defense Department chassis cabs because improperly tightened axle nuts may cause the driveshaft to disconnect.

    Product
    SPARTAN — SPARTAN METROSTAR, DEFENSE DEPT. CHASSIS CAB
    Category
    Vehicle
    Distribution
    Distributed nationwide