{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Jacksonville",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88586",
      "recalling_firm": "Medtronic Xomed, Inc.",
      "address_1": "6743 Southpoint Dr N",
      "address_2": "N/A",
      "postal_code": "32216-6218",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide, including PR. There was also government/military distribution and the countries of Australia, Austria, Bahrain, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kuwait, Latvia, Libya, Luxembourg, Macao, Malaysia, Mauritius, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Viet Nam.",
      "recall_number": "Z-0158-2022",
      "product_description": "Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers:    (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm;  (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm;  (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm;  (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm;  (5) REF 40S2500, Nucleus Removal Straight Blade, 25 cm x 4.0 mm;  (6) REF 45A2000, Nucleus Removal Angled Blade, 20 cm x 4.5 mm;  (7) REF 45A2500, Nucleus Removal Angled Blade, 25 cm x 4.5 mm;  (8) REF 45R2000, Nucleus Removal Set, 20 cm x 4.5 mm;  (9) REF 45R2500, Nucleus Removal Set, 25 cm x 4.5 mm;  (10) REF 45S2000, Nucleus Removal Straight Blade, 20 cm x 4.5 mm;  (11) REF 45S2500, Nucleus Removal Straight Blade, 25 cm x 4.5 mm.",
      "product_quantity": "274,991 total devices",
      "reason_for_recall": "There was an increase in complaints related to tip breaks and wobble/vibration.",
      "recall_initiation_date": "20210831",
      "center_classification_date": "20211021",
      "report_date": "20211027",
      "code_info": "(1) REF 40A2500, GTIN/UPN 00763000033835, Lot/serial number 0220002825;  (2) REF 40R2000, GTIN/UPN 00763000033866, Lot/serial number 0218179458;  (3) REF 40R2500, GTIN/UPN 00763000033798, Lot/serial number 0218299192;  (4) REF 40S2000, GTIN/UPN 00763000033873, Lot/serial number 0218179459;  (5) REF 40S2500, GTIN/UPN 00763000043193, Lot/serial number 0220226674;  (6) REF 45A2000, GTIN/UPN 00763000033880, Lot/serial number 0220443669;  (7) REF 45A2500, GTIN/UPN 00763000043223, Lot/serial number 0218323602;  (8) REF 45R2000, GTIN/UPN 00763000033897, Lot/serial numbers 0218284087, 0218292178, 0218973633;  (9) REF 45R2500, GTIN/UPN 00763000033811, Lot/serial number 0218297618;  (10) REF 45S2000, GTIN/UPN 00763000033903, Lot/serial number 0218299193;  (11) REF 45S2500, GTIN/UPN 00763000043216, Lot/serial number 0218297619."
    }
  ]
}