{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Republic",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91984",
      "recalling_firm": "ROi CPS LLC",
      "address_1": "3000 E Sawyer Rd",
      "address_2": "N/A",
      "postal_code": "65738-2758",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of FL and MO.  There was no foreign/military/government distribution.",
      "recall_number": "Z-1438-2023",
      "product_description": "Sterile surgical convenience kits:    1.  regard Item Number:  880473001, OR01105A - Total Shoulder/Hip; 2.  regard Item Number:  880426004, OR01033D - Total Hip; 3.  regard Item Number:  880427003, OR01034C - Total Knee; 4.  regard Item Number:  880474001, OR01106A - Knee Arthroscopy; 5.  regard Item Number:  800772006, OR00977F - OH Total Knee Pack ; 6.  regard Item Number:  880403004, OR01009D - Extremity Pack; 7.  regard Item Number:  880472001, OR01104A - Basic Pack ; 8.  regard Item Number:  880470001, OR01102A - Total Knee ; 9.  regard Item Number:  800755006, OR00960F - OH Hip Pack ; 10.  regard Item Number:  880471001, OR01103A - Shoulder Arthroscopy ; 11.  regard Item Number:  880480001, OR01112A - Hand and Foot ; and 12.  regard Item Number:  880468001, OR01100A - Spine.",
      "product_quantity": "1,369 kits",
      "reason_for_recall": "The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use.  The light handle covers are a kit component.",
      "recall_initiation_date": "20230322",
      "center_classification_date": "20230425",
      "report_date": "20230503",
      "code_info": "1.  Lot #95080, exp. 9/7/2024, UDI (01)10194717114161(17)240907(10)95080; 2.  Lot #95381, exp. 5/30/2024, UDI (01)10194717112341(17)240530(10)95381; 3.  Lot #95516, exp. 9/30/2024, UDI (01)10194717112365(17)240930(10)95516; 4.  Lot #95388, exp. 10/29/2024, UDI (01)10194717114192(17)241029(10)95388; 5.  Lot #95310, exp. 10/27/2024, UDI (01)10194717112778(17)241027(10)95310; 6.  Lot #95503, exp. 12/31/2023, UDI (01)10194717112150(17)231231(10)95503; 7.  Lot #95667, exp. 10/29/2024, UDI (01)10194717113904(17)241029(10)95667; 8.  Lot #95634, exp. 11/30/2024, UDI (01)10194717114154(17)241130(10)95634; 9.  Lot #95555, exp. 11/29/2024, UDI (01)10194717111016(17)241129(10)95555; 10.  Lot #95769, exp. 10/29/2024, UDI (01)10194717114185(17)241029(10)95769; 11.  Lot #95422, exp. 11/30/2024, UDI (01)10194717114178(17)241130(10)95422; and 12.  Lot #95633, exp. 10/17/2024, UDI (01)10194717113713(17)241017(10)95633."
    }
  ]
}