The Recall Desk

State

American Samoa product recalls

72,936 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 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3276–3300 of 72961

  • ModerateFDA (Devices)·Z-1240-2026·2026-02-11

    NAEOTOM Alpha software applications recalled because they lack FDA clearance

    Siemens is removing three software applications from 88 NAEOTOM Alpha CT systems because the applications have not received FDA 510(k) clearance.

    Product
    NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2026·2026-02-11

    Oxiris sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 2,724 Oxiris Sets because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1221-2026·2026-02-11

    Hematology diluents recalled over elevated platelet background check counts

    Beckman Coulter is recalling 76,098 units of COULTER DxH Diluent and DxH ECO Diluent because specific lots contribute to elevated platelet Daily Checks background counts.

    Product
    COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2026·2026-02-11

    Prismaflex M100 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 230,596 Prismaflex M100 Sets because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2026·2026-02-11

    Illuminated depressors recalled with no reason given in the record

    Vortex Surgical is recalling the TID Pharos Illuminated Depressor, VS0801B. The reason field in the enforcement record reads only "XXX", so no hazard is stated.

    Product
    Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0442-2026·2026-02-11

    Collagen supplement recalled over manganese below the labeled quantity

    Optiwize is recalling 78 units of OptiWize Collagen Plus, 320 count, after NSF testing showed the manganese level was below the label quantity.

    Product
    OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1294-2026·2026-02-11

    Triple lumen sphincterotomes recalled over a skipped thermoforming step

    Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0725, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1268-2026·2026-02-11

    CleverCut sphincterotomes recalled over a skipped thermoforming step

    Olympus is recalling the CleverCut Single Use 3-Lumen Sphincterotome V, model KD-V411M-0320, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1269-2026·2026-02-11

    Sphincterotome KD-VC431Q-0720 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use Sphincterotome V (Distal Wire guided), model KD-VC431Q-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1281-2026·2026-02-11

    Sphincterotome KD-VC411Q-0330 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0330, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1296-2026·2026-02-11

    Sphincterotome KD-V411M-3025 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3025, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1300-2026·2026-02-11

    Bubble sensors recalled over connecting cables that can be damaged

    Maquet Cardiopulmonary is recalling 3,050 Bubble Sensors because excessive bending of the connecting cable can damage the Venous Bubble Sensor or cause loose cable contact.

    Product
    Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1310-2026·2026-02-11

    Hoist sling bars recalled after a lifting bar mounting bolt broke

    ETAC A/S is recalling 64 units of Molift 2-point sling bars, accessories to mobile hoists after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.

    Product
    Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1291-2026·2026-02-11

    Sphincterotome KD-V411M-1530 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-1530, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2026·2026-02-11

    Sphincterotome KD-VC411Q-0725 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0725, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1278-2026·2026-02-11

    Distal wire guided sphincterotomes recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1224-2026·2026-02-11

    Prismaflex ST100 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 87,436 units of the PRISMAFLEX ST100 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1289-2026·2026-02-11

    Sphincterotome KD-401Q-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1292-2026·2026-02-11

    Sphincterotome KD-V411M-3030 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3030, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1280-2026·2026-02-11

    Sphincterotome KD-VC411Q-0320 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0320, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1293-2026·2026-02-11

    Sphincterotome KD-401Q-0320 recalled over a skipped thermoforming step

    Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0320, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1229-2026·2026-02-11

    Prismaflex HF1000 set 107140 recalled over a dislodging deaeration chamber

    Vantive US Healthcare is recalling 93,576 Prismaflex HF1000 Sets, product code 107140, because the deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1295-2026·2026-02-11

    Sphincterotome KD-V411M-3020 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3020, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2026·2026-02-11

    SOMATOM X.ceed software applications recalled over missing FDA clearance

    Siemens is removing three software applications from two SOMATOM X.ceed CT systems because the applications have not received FDA 510(k) clearance.

    Product
    SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1273-2026·2026-02-11

    Single use 3-lumen sphincterotomes recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0725, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide