The Recall Desk

State

American Samoa product recalls

73,478 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 73,478 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

23126–23150 of 73503

  • HighFDA (Devices)·Z-0045-2022·2021-10-13

    ZOLL COOL LINE Catheter Kit recalled for potential tubing leaks

    ZOLL has recalled its COOL LINE Intravascular Heat Exchange Catheter Kit due to potential leaks in catheter and tubing components, affecting approximately 6,395 units distributed worldwide.

    Product
    ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2022·2021-10-13

    Vantage Total Ankle System Recalled for Inadequate Packaging Barriers

    Exactech recalls Vantage Total Ankle System components due to vacuum-sealed packaging lacking an oxygen barrier layer, which could allow oxidative degradation of polyethylene inserts over time.

    Product
    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0048-2022·2021-10-13

    Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Recall for Potential Leaks

    Zoll Circulation recalls approximately 20,475 QUATTRO intravascular heat exchange catheter kits distributed worldwide due to potential leaks from the catheter or start-up kit tubing.

    Product
    Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2022·2021-10-13

    ZOLL Solex 7 IV Disposable Kit Recalled for Potential Catheter and Tubing Leaks

    ZOLL Circulation, Inc. is recalling the Solex 7 IV Disposable Pack and Start UP Kit due to potential leaks in catheter and tubing components. The Class II recall affects 79 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0066-2022·2021-10-13

    Zoll SOLEX 7(Heparin) IVTM Kit Recall: Potential Catheter and Tubing Leaks

    ZOLL Circulation is recalling 322 bundle kits of SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The affected kits have been distributed worldwide.

    Product
    Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2022·2021-10-13

    Medtronic Insertion Kits Recalled for Incorrect Guidewire Label Mix-Up

    Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.

    Product
    Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2022·2021-10-13

    Zoll ICY IV Disposable Pack Recall: Potential Catheter and Tubing Leaks

    ZOLL Circulation recalls the ICY IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 42 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0053-2022·2021-10-13

    ZOLL QUATTRO Intravascular Catheter Kit Labeling Update for Potential Leaks

    ZOLL Circulation is updating labeling for its QUATTRO Intravascular Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The update affects 1,733 units distributed worldwide.

    Product
    Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2022·2021-10-13

    ZOLL ICY Intravascular Catheter Kit Recalled for Potential Catheter and Tubing Leaks

    ZOLL Circulation is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The recall affects 58 kits distributed worldwide.

    Product
    Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0076-2022·2021-10-13

    Cardiosave IABP helium indicator may show inaccurate readings during electromagnetic interference

    Datascope Corp. is recalling Cardiosave Rescue IABP devices because the helium indicator may overrepresent the amount of helium in the unit when electromagnetic interference is present.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2022·2021-10-13

    Philips Ultrasound Sparq System Recalled Due to Intermittent Shutdown Risk

    Philips Ultrasound recalls the Sparq diagnostic ultrasound system due to a battery system data issue causing intermittent device shutdowns, regardless of actual battery status or AC power connection. Affected units were distributed in 10 US states and internationally.

    Product
    Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2022·2021-10-13

    ZOLL Premium Access Kit SOLEX 7 Catheter Kit Labeling Update on Potential Leaks

    ZOLL has issued a labeling update for its Premium Access Kit SOLEX 7 intravascular heat exchange catheter regarding potential leaks from the catheter or tubing. Approximately 5,524 kits were distributed worldwide.

    Product
    ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0046-2022·2021-10-13

    ZOLL ICY Intravascular Catheter Kit: Labeling Update for Potential Leaks

    ZOLL Circulation recalls 333 units of its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update addresses the leak risk affecting medical facilities worldwide.

    Product
    ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2022·2021-10-13

    Zoll Cool Line Catheter Kits Recalled Due to Potential Tubing Leaks

    ZOLL Circulation recalls Cool Line (Heparin) IVTM catheter kits due to potential leaks in catheter or start-up kit tubing. The recall affects 144 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0013-2022·2021-10-13

    Paltop Scan Abutment SP Recalled for Dimensional Tolerance Deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment SP devices due to manufacturing tolerance deviations that may delay dental restoration. Affected devices showed orientation misalignment and size engraving errors.

    Product
    Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2022·2021-10-13

    Medical Device Calibrator Kit Recall for Incorrect Labeling

    FDA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit due to incorrectly labeled calibrator vials in Lot 00681Y600. The labeling error prevents the instrument from completing calibration successfully.

    Product
    Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2022·2021-10-13

    Orthopedic Knee Implants Lack Protective Oxygen Barrier in Packaging

    Exactech OPTETRAK Comprehensive Knee System inserts were packaged in vacuum bags lacking an additional oxygen barrier layer, which could allow material degradation. The recall affects 2,774 devices distributed worldwide.

    Product
    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2022·2021-10-13

    Zoll ICY Intravascular Catheter Kit: Labeling Update on Potential Leaks

    ZOLL is updating labeling for ICY Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or tubing. Healthcare providers should review updated guidance from the manufacturer.

    Product
    Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0019-2022·2021-10-13

    OPTETRAK Comprehensive Knee System components recalled for inadequate packaging barrier

    Exactech is recalling approximately 242,397 OPTETRAK Comprehensive Knee System tibial components due to inadequate oxygen barrier in vacuum bag packaging. No injuries have been reported.

    Product
    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0037-2022·2021-10-13

    Medical cooler-heater device recalled for inadequate maintenance and inspection guidance

    CardioQuip is recalling 1,646 units of its Modular Cooler-Heater 1000(m) due to inadequate labeling. The device documentation lacks guidance on proper water-quality maintenance and inspection procedures required for safe operation.

    Product
    CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0038-2022·2021-10-13

    Cardiac Cooler-Heater Device Lacks Maintenance and Inspection Guidance

    CardioQuip is recalling its Modular Cooler-Heater device because labeling omits proper guidance for water-quality maintenance and device inspection, affecting users' ability to maintain the device correctly.

    Product
    CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0050-2022·2021-10-13

    Zoll ICY Heat Exchange Catheter Kit Labeling Update Due to Potential Leaks

    ZOLL Circulation is updating labeling for its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 1,256 units distributed worldwide.

    Product
    Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0017-2022·2021-10-13

    Scan Abutment PCA dental implant component recalled for tolerance deviations

    Paltop Advanced Dental Solutions is recalling Scan Abutment PCA devices due to manufacturing tolerance deviations that may delay implant restoration. Some devices show up to 2-degree orientation variance and sizing discrepancies.

    Product
    Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0022-2022·2021-10-13

    OPTETRAK Comprehensive Knee System Custom Inserts Recalled for Packaging Defect

    Exactech, Inc. is recalling 41 custom OPTETRAK knee implant inserts due to packaging defects. The inserts were packaged in vacuum bags lacking adequate oxygen barrier protection.

    Product
    OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2022·2021-10-13

    Dental implant abutments recalled for orientation and sizing tolerance issues

    Paltop Advanced Dental Solutions is recalling Scan Abutment SU devices (Catalog No. 30-70104) manufactured before July 21, 2021, due to manufacturing tolerance deviations that may delay dental restoration.

    Product
    Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide