{
  "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": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92399",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "address_2": "N/A",
      "postal_code": "60093-2753",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.",
      "recall_number": "Z-2333-2023",
      "product_description": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N;       b. CUSTOM GYN, Model Number: DYNJ63257B;     c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C;    d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F;       e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F;       f. DBD-GYN LS, Model Number: DYNJ906616G;       g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I;       h. GYN EXP LAPAROTOMY, Model Number: DYNJ906578D;       i. GYN LITHOTOMY, Model Number: DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F;       j. GYN LS, Model Number: DYNJ906616A, DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F;       k. GYN ROBOTIC CUSTOM PACK-LF, Model Number: DYNJ0752001K;       l. ROBOTIC, Model Number: DYNJ904343D, DYNJ904343F;       m. ROBOTIC GYN SSC, Model Number: DYNJ60009B, DYNJ60009C;       n. ROBOTIC PACK-LF, Model Number: DYNJ904250G;       o. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826G;       p. ROBOTIC-LF, Model Number: DYNJ904254G, DYNJ904254I;      q. ROBOTICS GYN, Model Number: DYNJ905824F, DYNJ905824G, DYNJ905824I;       r. SSC GU ROBOTIC PACK, Model Number: DYNJ64027A, DYNJ64027B;",
      "product_quantity": "7,462 kits",
      "reason_for_recall": "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.",
      "recall_initiation_date": "20230515",
      "center_classification_date": "20230803",
      "report_date": "20230809",
      "code_info": "All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023:    a. Model Number: DYNJ902540N, UPC Number: 019348991666.   b. Model Number: DYNJ63257B, UPC Number: 019348942817.   c. Model Number: DYNJ0771979C, UPC Number: 019348940069.   d. Model Number: DYNJ906578F, UPC Number: 019532728963.   e. Model Number: DYNJ906579F, UPC Number: 019532728964.   f. Model Number: DYNJ906616G, UPC Number: 019532728947.   g. Model Number: DYNJ905824I, UPC Number: 019532728972.   h. Model Number: DYNJ906578D, UPC Number: 019532721712.   i. Model Number: DYNJ906579A, UPC Number: 019348942214; Model Number: DYNJ906579B, UPC Number: 019348986153; Model Number: DYNJ906579D, UPC Number: 019532721713; Model Number: DYNJ906579F, UPC Number: 019532728964.   j. Model Number: DYNJ906616A, UPC Number: 019348942213; Model Number: DYNJ906616B, UPC Number: 019348986167; Model Number: DYNJ906616C, UPC Number: 019532702358; Model Number: DYNJ906616D, UPC Number: 019532714503; Model Number: DYNJ906616F, UPC Number: 019532721728.   k. Model Number: DYNJ0752001K, UPC Number: 019348978302.   l. Model Number: DYNJ904343D, UPC Number: 019348991389; Model Number: DYNJ904343F, UPC Number: 019532714890.   m. Model Number: DYNJ60009B, UPC Number: 019532705797; Model Number: DYNJ60009C, UPC Number: 019532720643.   n. Model Number: DYNJ904250G, UPC Number: 019532717379.   o. Model Number: DYNJ905826G, UPC Number: 019532728973.   p. Model Number: DYNJ904254G, UPC Number: 019532700342; Model Number: DYNJ904254I, UPC Number: 019532704701.   q. Model Number: DYNJ905824F, UPC Number: 019532702351; Model Number: DYNJ905824G, UPC Number: 019532721704; Model Number: DYNJ905824I, UPC Number: 019532728972.   r. Model Number: DYNJ64027A, UPC Number: 019532705798; Model Number: DYNJ64027B, UPC Number: 019532720644."
    }
  ]
}