{
  "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-2307-2023",
      "product_description": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B;       b. BASIC BIOPSY TRAY, Model Number: DYNDH1534;     c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485;       d. BIOPSY PACK-LF, Model Number: DYNJ0747885G;       e. BIOPSY RAD CT, Model Number: DYNJ59752A;       f. BIOPSY TRAY, Model Number: DYNDH1748, DYNJ34637F, DYNJ34637G, DYNJ43076, DYNJ43076A, DYNJ62690;       g. BIOPSY WITH PROB COVER WRO-LF, Model Number: DYNJ42307A;       h. BREAST BIOPSY KIT, Model Number: DYNDA1224B;       i. BREAST BIOPSY TRAY, Model Number: DYNDH1266, DYNDH1302, DYNDH1345A, DYNDH1677;       j. CABARRUS BIOPSY TRAY, Model Number: DYNDH1670;        k. CORE BIOPSY PACK-LF, Model Number: DYNJ42752A;       l. GENERAL BIOPSY PACK, Model Number: P365500;       m. IGT BIOPSY PACK-LF, Model Number: DYNJ38616A;       n. IR BIOPSY PACK, Model Number: DYNJ63688I;       o. PROSTATE BIOPSY, Model Number: DYNJVB91015A;       p. PROSTATE BIOPSY PACK, Model Number: DYNJ56578;       q. RENAL BIOPSY TRAY, Model Number: SPEC0168;       r. REVAMP BIOPSY TRAY, Model Number: DYNDH1147A;       s. SOFT TISSUE BIOPSY, Model Number: DYNDH1750;       t. THYROID BIOPSY TRAY, Model Number: DYNDH1288;       u. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C;       v. UL BIOPSY TRAY, Model Number: DYNDH1778;       w. ULTRASOUND BIOPSY, Model Number: DYNDH1542B;       x. ULTRASOUND BREAST BIOPSY, Model Number: DYNDH1496A;       y. ULTRASOUND CORE BIOPSY TRAY, Model Number: DYNDH1786;       z. US BREAST BIOPSY PACK, Model Number: DYNJ61992B;",
      "product_quantity": "43,613 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: DYNJ53658B, UPC Number: 019532708870.   b. Model Number: DYNDH1534, UPC Number: 019348919708.   c. Model Number: DYNDH1124, UPC Number: 088994230327; Model Number: DYNJ50485, UPC Number: 088827799279; Model Number: DYNDH1124, UPC Number: 10889942303274.   d. Model Number: DYNJ0747885G, UPC Number: 019532708872.   e. Model Number: DYNJ59752A, UPC Number: 019348959857.   f. Model Number: DYNDH1748, UPC Number: 019532716474; Model Number: DYNJ34637F, UPC Number: 019348956435; Model Number: DYNJ34637G, UPC Number: 019348936880; Model Number: DYNJ43076, UPC Number: 088827702453; Model Number: DYNJ43076A, UPC Number: 019532708062; Model Number: DYNJ62690, UPC Number: 019348968226.   g. Model Number: DYNJ42307A, UPC Number: 088827729875.   h. Model Number: DYNDA1224B, UPC Number: 019348946851.   i. Model Number: DYNDH1266, UPC Number: 088994267045; Model Number: DYNDH1302, UPC Number: 088994276804; Model Number: DYNDH1345A, UPC Number: 088827773293; Model Number: DYNDH1677, UPC Number: 019532704448.   j. Model Number: DYNDH1670, UPC Number: 019532701068.   k. Model Number: DYNJ42752A, UPC Number: 088994232609.    l. Model Number: P365500, UPC Number: 088994214185.   m. Model Number: DYNJ38616A, UPC Number: 088438975595.   n. Model Number: DYNJ63688I, UPC Number: 019532703723.   o. Model Number: DYNJVB91015A, UPC Number: 019348933972.   p. Model Number: DYNJ56578, UPC Number: 088994265947.   q. Model Number: SPEC0168, UPC Number: 088438986986.   r. Model Number: DYNDH1147A, UPC Number: 019348934879.   s. Model Number: DYNDH1750, UPC Number: 019532716642.   t. Model Number: DYNDH1288, UPC Number: 088994272663.   u. Model Number: DYNDH1121C, UPC Number: 019348946865.   v. Model Number: DYNDH1778, UPC Number: 019532722847.   w. Model Number: DYNDH1542B, UPC Number: 019532725147.   x. Model Number: DYNDH1496A, UPC Number: 019348982531.   y. Model Number: DYNDH1786, UPC Number: 019532722955.   z. Model Number: DYNJ61992B, UPC Number: 019532729265."
    }
  ]
}