The Recall Desk

State

American Samoa product recalls

73,388 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 73,388 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

21526–21550 of 73413

  • HighFDA (Devices)·Z-0687-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MRI Safety Claims

    BioPro Titanium MPJ toe implant documentation incorrectly claims MRI safety testing that was never conducted. The implant is not proven safe for MRI use.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MRI Safety Statements

    BioPro is recalling Titanium MPJ toe implants due to false claims of MRI compatibility. The device instruction manual states it is MRI-safe despite not being tested.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0711-2022·2022-03-09

    Bronchial Microbiology Brush Labeling Error—Cleared Only for Gastrointestinal Use

    Hobbs Medical is recalling 38,357 Bronchial Microbiology Brushes due to labeling that incorrectly indicates bronchial use. The device is cleared only for gastrointestinal use.

    Product
    Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2022·2022-03-09

    K2M Everest MI XT Outer Dilators recalled for manufacturing defect

    K2M is recalling 686 Everest MI XT Outer Dilator units due to a manufacturing nonconformance that prevents them from fitting properly with inner dilators during surgical procedures.

    Product
    Everest MI XT Outer Dilator, Catalog Number 5101-90168
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2022·2022-03-09

    K2M Everest MI XT Inner Dilator Recalled for Manufacturing Fit Defect

    K2M recalled 686 units of the Everest MI XT Inner Dilator due to a manufacturing nonconformance preventing proper fit with outer dilators during surgery. Two complaints prompted the recall.

    Product
    Everest MI XT Inner Dilator, Catalog Number 5101-90167
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0684-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant MRI Safety Labeling Error

    BioPro is recalling Titanium MPJ toe implants due to false MRI safety labeling. The instructions and patient cards incorrectly state the device was tested for MRI safety, but no testing was conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0708-2022·2022-03-09

    OPAQUE Lacrimal Plugs recalled due to sterile pouch seal defect

    Lacrimedics is recalling approximately 5,767 units of OPAQUE Lacrimal Plugs due to potential defects in the sterile pouch seal that could compromise product sterility. The affected devices were distributed nationwide and internationally.

    Product
    OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0698-2022·2022-03-09

    QC Control Panels Fail Shelf Life Stability Test at 24 Months

    Microbiologics QC control panels for bacterial diagnostic testing failed shelf life validation at 24 months. The 29 affected units were distributed across US states and internationally to Canada, UK, Australia, Belgium, and India.

    Product
    Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22093·2022-03-09

    Danby Free-Standing and Slide-In Ranges Recalled for Tip-Over Hazard

    Danby is recalling about 1,700 free-standing and slide-in electric and gas ranges because the anti-tip-over bracket may not be securely installed, creating a tip-over hazard and risk of burn injuries when heavy objects are placed on an open oven door.

    Product
    Danby brand free-standing and slide-in electric and gas ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2022·2022-03-09

    Brasseler K-WIRE surgical instruments recalled for unsealed packaging

    Brasseler USA is recalling 231 units of K-WIRE Double Trocar Smooth surgical instruments due to unsealed packaging that may compromise sterility.

    Product
    Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2022·2022-03-09

    BioPro Titanium Toe Implant Recalled for Incorrect MRI Safety Claims

    BioPro Titanium MPJ toe implants contain incorrect documentation falsely claiming they are MR Conditional without proper testing. Patients should not assume these implants are safe for MRI.

    Product
    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2022·2022-03-09

    Titanium Toe Implant Recalled for Incorrect MR Compatibility Claims

    BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0701-2022·2022-03-09

    Helix Elite Molecular Standards recalled due to shelf life test failure

    Microbiologics Inc is recalling Helix Elite Molecular Standards for Inactivated Influenza A/B and Respiratory Syncytial Virus because shelf life testing failed at 24 months, potentially affecting product stability.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2022·2022-03-09

    Lacrimedics Collagen Plugs recalled for potential sterility seal compromise

    Lacrimedics is recalling Collagen Plugs (models CP3, CP4, CP5) due to potential seal integrity defects in sterile pouches. The seals may contain channels that could compromise sterility and allow contamination.

    Product
    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0714-2022·2022-03-09

    Quality Control Kit Bacterial Strain Shows Unexpected Gentamicin Susceptibility

    Microbiologics has recalled KWIK-STIK quality control kits due to a specific lot failing to meet resistance specifications for Gentamicin Synergy. The affected bacterial strain showed unexpected susceptibility when it should have been resistant.

    Product
    KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0704-2022·2022-03-09

    Diagnostic Quality Control Material Yields False-Positive Results in GBS Testing

    A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.

    Product
    QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0636-2022·2022-03-09

    TSM Brands Isopropyl Alcohol Recalled for Undeclared Ethyl Alcohol

    TSM Brands LLC is recalling Luxury 70% Isopropyl Alcohol bottles nationwide because the product contains undeclared ethyl alcohol that is not identified on the label.

    Product
    Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0635-2022·2022-03-09

    70% Isopropyl Alcohol First Aid Antiseptic Contains Undeclared Ethyl Alcohol

    TSM Brands LLC is recalling 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen due to undeclared ethyl alcohol in the product. The recall affects bottles distributed nationwide.

    Product
    70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0697-2022·2022-03-09

    Microbiologics QC Panel Recalled Due to Shelf Life Testing Failure

    Microbiologics Inc is recalling its Helix Elite Extended Enteric Bacterial Verification Panel because real-time shelf life testing failed at 24 months.

    Product
    Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0632-2022·2022-03-09

    Amlodipine and Olmesartan Medoxomil Tablets Recalled for cGMP Deviations

    Macleods Pharma USA is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated by the manufacturer.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0703-2022·2022-03-09

    QC Control Sets for GBS Testing Recalled Due to Contamination

    Microbiologics QC sets used for GBS testing contain a negative control contaminated with Group B Streptococcus, causing test failures. Affects 541 units distributed nationwide.

    Product
    QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0642-2022·2022-03-09

    Alprazolam Tablets 1mg Recalled for CGMP Deviations

    Preferred Pharmaceuticals is recalling 276 bottles of Alprazolam Tablets USP 1mg (generic Xanax) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.

    Product
    Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2022·2022-03-09

    LYFO-DISK Quality Control Kit Lot Fails Antibiotic Resistance Specification

    A lot of LYFO-DISK quality control kit was found susceptible to Gentamicin Synergy when it should have been resistant. The 153 affected units were distributed worldwide.

    Product
    LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2022·2022-03-09

    BioPro Titanium MPJ Toe Implant Recalled for Incorrect MR Compatibility Labeling

    BioPro is recalling Titanium MPJ toe implants because instructions and patient cards falsely claim the devices are compatible with MRI imaging, when safety testing for this titanium version has not been conducted.

    Product
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
    Category
    Medical Device
    Distribution
    Distributed nationwide