{
  "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-2317-2023",
      "product_description": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031;       b. BREAST, Model Number: DYNJ904598B;     c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893;       d. BREAST PACK, Model Number: DYNDH1306;       e. BRST BX TRAY, Model Number: DYNDH1389B;       f. CMC BREAST BIOPSY TRAY-LF, Model Number: DYNJ61084A;       g. DBD-DIEP PACK, Model Number: DYNJ60669F;       h. DBD-FREE FLAP, Model Number: DYNJ907802;       i. DBD-FREE FLAP PACK, Model Number: DYNJ83286;       j. DBD-MAJOR BREAST, Model Number: DYNJ905004B;       k. DBD-PLASTICS FREE FLAP, Model Number: SYNJ910024A;       l. DELNOR SIMPLE PLASTIC PACK, Model Number: DYNJ82250;       m. DIEP, Model Number: DYNJ905702C, DYNJ905702D;       n. DIEP FLAP CDS, Model Number: DYNJ904762D;       o. DIEP PACK, Model Number: DYNJ60669C, DYNJ60669D;       p. FH BREAST FLAP PACK, Model Number: DYNJ58272C, DYNJ58272D;       q. FLAP KIT, Model Number: DYNJ900845B;       r. FLAP PACK, Model Number: DYNJ48191G, DYNJ48191I, DYNJ48191J, DYNJ60224B;       s. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388P;       t. FREE FLAP, Model Number: DYNJ906823A, DYNJ906823B;       u. FREE FLAP 1 PACK, Model Number: DYNJ82660;       v. FREE FLAP 2 PACK, Model Number: DYNJ82659;       w. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320L;       x. FREE FLAP CDS, Model Number: CDS983996B;       y. FREE FLAP CUSTOM PACK B, Model Number: DYNJ82736;       z. FREE FLAP DONOR, Model Number: DYNJ44483B;       aa. FREE FLAP PACK, Model Number: DYNJ83286;       bb. FREE FLAP PACK-LF, Model Number: DYNJ0271254O, DYNJ20495I, DYNJ42833A, DYNJ42833B, PHS656679003;       cc. FREE FLAP RECIPIENT, Model Number: DYNJ44484D, DYNJ44484F;       dd. MAIN FLAP, Model Number: DYNJ908264;       ee. MAJOR BREAST, Model Number: DYNJ905004A, DYNJ908890;       ff. MINOR BREAST, Model Number: DYNJ905002B, DYNJ908892;       gg. PK GEN BREAST RESTON, Model Number: DYNJ84305;       hh. PLASTIC DIEP PACK, Model Number: DYNJ81727, DYNJ81727A;       ii. PLASTIC FREE FLAP, Model Number: DYNJ67367, DYNJ67367A;       jj. PLASTIC FREE FLAP PACK, Model Number: DYNJ82758;       kk. PLASTIC MICROVASCULAR, Model Number: DYNJ908181, DYNJ908181A, DYNJ908181B;       ll. PLASTIC PACK, Model Number: DYNJ35262A;       mm. PROCEDURE PACK, Model Number: DYNJ55063;       nn. RO-DIEP PACK, Model Number: DYNJ82393;       oo. SDS MN BREAST PACK, Model Number: DYNJ57719C, DYNJ57719D;       pp. VNUS RFS PROCEDURE PACK, Model Number: DYNJ39508A;",
      "product_quantity": "11,436 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: DYNJ909031, UPC Number: 019532725061.   b. Model Number: DYNJ904598B, UPC Number: 088994294635.   c. Model Number: DYNJ63893, UPC Number: 019348977156.   d. Model Number: DYNDH1306, UPC Number: 088994277152.   e. Model Number: DYNDH1389B, UPC Number: 019348944918.   f. Model Number: DYNJ61084A, UPC Number: 019348969202.   g. Model Number: DYNJ60669F, UPC Number: 019532728956.   h. Model Number: DYNJ907802, UPC Number: 019348989000.   i. Model Number: DYNJ83286, UPC Number: 019532725665.   j. Model Number: DYNJ905004B, UPC Number: 019348978258.   k. Model Number: SYNJ910024A, UPC Number: 019348937448.   l. Model Number: DYNJ82250, UPC Number: 019532718175.   m. Model Number: DYNJ905702C, UPC Number: 019532700467; Model Number: DYNJ905702D, UPC Number: 019532717382.   n. Model Number: DYNJ904762D, UPC Number: 019532725881.   o. Model Number: DYNJ60669C, UPC Number: 019532702362; Model Number: DYNJ60669D, UPC Number: 019532721717.   p. Model Number: DYNJ58272C, UPC Number: 019348989552; Model Number: DYNJ58272D, UPC Number: 019532714511.   q. Model Number: DYNJ900845B, UPC Number: 088994263442.   r. Model Number: DYNJ48191G, UPC Number: 019348947660; Model Number: DYNJ48191I, UPC Number: 019532705781; Model Number: DYNJ48191J, UPC Number: 019532725503; Model Number: DYNJ60224B, UPC Number: 019348987735.   s. Model Number: DYNJ0378388P, UPC Number: 019532708997.   t. Model Number: DYNJ906823A, UPC Number: 019348989447; Model Number: DYNJ906823B, UPC Number: 019532702707.   u. Model Number: DYNJ82660, UPC Number: 019532719933.   v. Model Number: DYNJ82659, UPC Number: 019532719932.   w. Model Number: DYNJ0991320L, UPC Number: 019532702854.   x. Model Number: CDS983996B, UPC Number: 088994213130.   y. Model Number: DYNJ82736, UPC Number: 019532720755.   z. Model Number: DYNJ44483B, UPC Number: 088994281894.   aa. Model Number: DYNJ83286, UPC Number: 019532725665.   bb. Model Number: DYNJ0271254O, UPC Number: 019348956435; Model Number: DYNJ20495I, UPC Number: 019348956435; Model Number: DYNJ42833A, UPC Number: 088827750399; Model Number: DYNJ42833B, UPC Number: 019348988033; Model Number: PHS656679003, UPC Number: 088994204000.   cc. Model Number: DYNJ44484D, UPC Number: 088994281895; Model Number: DYNJ44484F, UPC Number: 019348948834.   dd. Model Number: DYNJ908264, UPC Number: 019532702011.   ee. Model Number: DYNJ905004A, UPC Number: 088994291171, Model Number: DYNJ908890, UPC Number: 019532720339.   ff. Model Number: DYNJ905002B, UPC Number: 019532731686, Model Number: DYNJ908892, UPC Number: 019532720403.   gg. Model Number: DYNJ84305, UPC Number: 019532734981.   hh. Model Number: DYNJ81727, UPC Number: 019532713711; Model Number: DYNJ81727A, UPC Number: 019532727789.    ii. Model Number: DYNJ67367, UPC Number: 019348989571; Model Number: DYNJ67367A, UPC Number: 019532723070.   jj. Model Number: DYNJ82758, UPC Number: 019532720744.   kk. Model Number: DYNJ908181, UPC Number: 019532700174; Model Number: DYNJ908181A, UPC Number: 019532706226; Model Number: DYNJ908181B, UPC Number: 019532724293.   ll. Model Number: DYNJ35262A, UPC Number: 019348990343.   mm. Model Number: DYNJ55063, UPC Number: 088994252657.   nn. Model Number: DYNJ82393, UPC Number: 019532718973.   oo. Model Number: DYNJ57719C, UPC Number: 019348976734; Model Number: DYNJ57719D, UPC Number: 019348994582.   pp. Model Number: DYNJ39508A, UPC Number: 088994262891."
    }
  ]
}