The Recall Desk

State

American Samoa product recalls

72,940 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 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5101–5125 of 72965

  • HighFDA (Devices)·Z-2563-2025·2025-09-24

    CD20 antibody reagent recalled over weak staining causing false negative results

    FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis is recalled because of the potential for weak staining, which may result in false negative CD20 identification. 4,145 units are affected.

    Product
    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0645-2025·2025-09-24

    Aripiprazole 10 mg tablets recalled after testing superpotent in one lot

    Aripiprazole Tablets, USP, 10 mg, lot 24144162, distributed by Ascend Laboratories, are recalled nationwide as a superpotent drug. 2,256 bottles are affected.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2025·2025-09-24

    CD20 antibody lots recalled over weak staining risking false negative results

    FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2J, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 67 units are affected.

    Product
    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0646-2025·2025-09-24

    Compounded bevacizumab syringes recalled for lack of assurance of sterility

    Fagron Sterile Services bevacizumab (Avastin) Injection, 1.25 mg/0.05 mL single-dose syringes, is recalled nationwide for lack of assurance of sterility. 109,320 syringes are affected.

    Product
    bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2591-2025·2025-09-24

    Lubri-Sil Foley trays recalled over inserts describing the wrong catheter material

    SureStep Foley Tray Systems with Bard Lubri-Sil catheters, REF A942216 lot NGJX4320, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating. 3,670 units are affected.

    Product
    SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2589-2025·2025-09-24

    Bardex Foley catheter trays recalled over inserts describing the wrong material

    SureStep Foley Tray Systems, REF A303316A lot NGJX6399, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.

    Product
    SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2025·2025-09-24

    Reverse shoulder liners recalled over articular surface outside dimensional specification

    Exactech Equinoxe Reverse Shoulder humeral liners under REF 320-38 and 320-42 are recalled because the articular surface position falls outside the dimensional specification in the labeling. 61,334 units are affected.

    Product
    Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2575-2025·2025-09-24

    DxH 600 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 600 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2025·2025-09-24

    Heartstring III 3.8 mm seal systems recalled over three identified failure modes

    Heartstring III Proximal Seal Systems, 3.8 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 28,331 units are affected.

    Product
    Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2573-2025·2025-09-24

    Hematology analyzers recalled over erroneously high hemoglobin results in some samples

    UniCel DxH 690T Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0653-2025·2025-09-24

    Sodium chloride irrigation bags recalled over port misalignment allowing fluid leakage

    B. Braun 0.9% Sodium Chloride Irrigation USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 16,228 bags are affected.

    Product
    SODIUM CHLORIDE FOR IRRIGATION — SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2025·2025-09-24

    DxH 800 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 800 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2025·2025-09-24

    Heartstring III seal systems recalled over failures to load, deploy and seal

    Heartstring III Proximal Seal Systems, model HS-3045, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 126 units are affected.

    Product
    Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2025·2025-09-24

    DxH 900 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 900 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2588-2025·2025-09-24

    Heartstring III 4.3 mm seal systems recalled over loading and deployment failures

    Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.

    Product
    Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2025·2025-09-24

    Foley catheter trays recalled because inserts describe the wrong catheter material

    SureStep Foley Tray Systems, REF A303414A lot NGJY3685, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.

    Product
    SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25E059000·2025-09-24

    Lippert Paddle Latches Recalled for Risk of LP Compartment Fire

    Lippert is recalling specific paddle latches used on REV Recreation Group vehicles because they may lock unintentionally, preventing access to the liquid propane compartment and increasing fire risk.

    Product
    LATCHES/LOCKS/LINKAGES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2025·2025-09-24

    Shoulder humeral liners recalled over articular surface outside dimensional specification

    Exactech Equinoxe Reverse Shoulder humeral liners in 38 mm and 42 mm sizes are recalled because the articular surface position falls outside the dimensional specification in the labeling. 11,542 units are affected.

    Product
    Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2581-2025·2025-09-24

    Sixteen millimetre distraction pins recalled over unvalidated shelf life labeling

    Frontier Devices 16 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 490 units are affected.

    Product
    Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2560-2025·2025-09-24

    Lactate slides in 18-slide cartridges recalled over calibration failures delaying results

    VITROS Chemistry Products LAC Slides, catalog 8150112, from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,320 units are affected.

    Product
    VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2583-2025·2025-09-24

    Blood gas CG8+ cartridges recalled for lacking updated premarket clearance

    i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.

    Product
    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2585-2025·2025-09-24

    Blood gas EG6+ cartridges recalled for lacking updated premarket clearance

    i-STAT EG6+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 547,250 units are affected.

    Product
    i-STAT EG6+ cartridge. List Number: 03P77-25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2576-2025·2025-09-24

    Distraction pins in single packs recalled over shelf life that was not validated

    Frontier Devices 12 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 3,790 units are affected.

    Product
    Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide