{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 8
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  },
  "results": [
    {
      "cfres_id": "221383",
      "product_res_number": "Z-2812-2026",
      "event_date_initiated": "2026-06-17",
      "event_date_posted": "2026-07-27",
      "recall_status": "Open, Classified",
      "res_event_number": "99347",
      "product_code": "OFT",
      "product_description": "AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  SPINAL KIT, Part Number AMS13683A",
      "code_info": "UDI/DI B098AMS13683A0, Lot Number  230451",
      "firm_fei_number": "1000125955",
      "recalling_firm": "Windstone Medical Packaging, Inc.",
      "address_1": "1602 4th Ave N",
      "city": "Billings",
      "state": "MT",
      "postal_code": "59101-1521",
      "additional_info_contact": "406-259-6387",
      "reason_for_recall": "Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP.  Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.",
      "root_cause_description": "Material/Component Contamination",
      "action": "Aligned Medical Solutions (AMS) issues an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 6/17/2026 via email.  The notice explained the issue, potential risk, and requested the following:  \n\"AMS requests that you undertake the following activities:\n1. Immediately check your inventory for the recalled products listed above and place them under quarantine.\n2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each pack. This sticker will read:  \n'RECALL NOTICE\nELEVARIS announced the recall of Lidocaine 5mL Ampules contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall.  \n  \" At the time the kit is opened for use any Elevaris Lidocaine 5mL Ampule(s) should be identified and set aside.\n  \" The recalled Elevaris Lidocaine should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.'\n3. Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity.\n4. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter.\n5. Please complete the Recall Reply Form within 5 business days and return via email to fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand.\n6. Indicate on the Recall Reply Form if a replacement Lidocaine Ampules are needed.\"  \nfor questions or concerns, please do not hesitate to contact us at fieldcorrectiveaction@alignedmedicalsolutions.com.",
      "product_quantity": "15 kits",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.",
      "openfda": {
        "device_name": "Spinal Epidural Anesthesia Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5120",
        "device_class": "2",
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