{
  "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-2321-2023",
      "product_description": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B;     b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A;   c. PERC PACK-LF, Model Number: DYNJ0774759P;  d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D;     e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747;     f. PERIPHERAL PACK, Model Number: DYNJ44960D;     g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865;     h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B;     i. PERMACATH-LF, Model Number: DYNJ42262D;     j. PHLEBECTOMY PACK, Model Number: DYNJ47502B;     k. PHYSIATRY PACK, Model Number: DYNJ67414;     l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A;     m. PICC INSERTION PACK, Model Number: DYNJ60038;     n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F;     o. PICC LINE INSERTION, Model Number: DYNJ39885A;     p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B;     q. PICC LINE TRAY, Model Number: DYNJ52688A;     r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F;     s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717;     t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990;     u. PICC PROCEDURE PACK, Model Number: DYNJ59067;     v. PICC TRAY, Model Number: DYNJ49177F;     w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A;     x. PK GEN-RECIPIENT, Model Number: DYNJ41114C;     y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A;     z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A;     aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A;     bb. PORT INSERTION PACK, Model Number: CVI4765;     cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990;     dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C;     ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393;     ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B;     gg. PREP TRAY, Model Number: DYNJRA1498;     hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968;     ii. PUH AV FISTULA CDS, Model Number: CDS984329J;     jj. PURPLE PACK, Model Number: DYNJ62197;     kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F;     ll. PV PACK, Model Number: DYNJ46549J;     mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131;     nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B;     oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A;     pp. RADIOLOGY PACK, Model Number: DYNJ42172A;     qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B;     rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M;     ss. RADIOLOGY TRAY, Model Number: MNS11625;     tt. RECIPIENT PACK, Model Number: DYNJ41114B;     uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256;     vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899;     ww. RIGHT HEART TRAY, Model Number: DYNJ40379C;     xx. ROBOT, Model Number: DYNJ906112;     yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A;     zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F;     aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J;     bbb. RR-SPECIAL PROCEDURE  PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O;     ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A;     ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M;     eee. SMH VASCULAR CDS, Model Number: CDS984584L;     fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C;     ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y;     hhh. SPECIALS PACK, Model Number: DYNJ67504A;     iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B;     jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027;     kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J;     lll. STERILE INJECTION PACK, Model Number: DYNDA2805;     mmm.  SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958;     nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C;     ooo. SVMMC VASCULAR MAJOR PA",
      "product_quantity": "233,638 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: DYNJ54755B, UPC Number: 088994292536.   b. Model Number: DYNJ40306A, UPC Number: 088994260192.   c. Model Number: DYNJ0774759P, UPC Number: 019532724613.   d. Model Number: DYNJ902261D, UPC Number: 088994275524.   e. Model Number: DYNJRA1747, UPC Number: 019348946400.   f. Model Number: DYNJ44960D, UPC Number: 019348983324.   g. Model Number: DYNDV2285, UPC Number: 019348919454; Model Number: MNS9865, UPC Number: 065316029443.   h. Model Number: DYNJ904401B, UPC Number: 019348968343.   i. Model Number: DYNJ42262D, UPC Number: 088994269795.   j. Model Number: DYNJ47502B, UPC Number: 019348964922.   k. Model Number: DYNJ67414, UPC Number: 019348996464.   l. Model Number: PHS41739A, UPC Number: 088994290680.   m. Model Number: DYNJ60038, UPC Number: 088827779327.   n. Model Number: CDS982858F, UPC Number: 088827773921.   o. Model Number: DYNJ39885A, UPC Number: 088994253993.   p. Model Number: DYNJ41873B, UPC Number: 019348956306.   q. Model Number: DYNJ52688A, UPC Number: 088994284356.   r. Model Number: CDS982859F, UPC Number: 088827773920.   s. Model Number: DYNJ47717, UPC Number: 088827751458.   t. Model Number: DYNJ55723A, UPC Number: 088994286553; Model Number: DYNJ60990, UPC Number: 019348953847.   u. Model Number: DYNJ59067, UPC Number: 088994293004.   v. Model Number: DYNJ49177F, UPC Number: 088827777434.   w. Model Number: DYNDC2399A, UPC Number: 088994244693.   x. Model Number: DYNJ41114C, UPC Number: 019532726173.   y. Model Number: DYNJ54894A, UPC Number: 019348921355.   z. Model Number: DYNJ54894A, UPC Number: 019348921355.   aa. Model Number: DYNJ54982A, UPC Number: 019348980895.   bb. Model Number: CVI4765, UPC Number: 019348995318.   cc. Model Number: DYNJ56857B, UPC Number: 019348989314; Model Number: DYNJ68990, UPC Number: 019348987261.   dd. Model Number: DYNDA1468C, UPC Number: 088994284317; Model Number: DYNDA1468C, UPC Number: 10889942843176.   ee. Model Number: DYNJ64393, UPC Number: 019348980963.   ff. Model Number: DYNJRA1155B, UPC Number: 019348958371; Model Number: DYNJRA1200B, UPC Number: 019348956827.   gg. Model Number: DYNJRA1498, UPC Number: 019348979574.  hh. Model Number: DYNJ55063A, UPC Number: 019348968054; Model Number: DYNJ57674A, UPC Number: 088827777174; Model Number: DYNJ59795A, UPC Number: 019348956698; Model Number: DYNJ62588, UPC Number: 019348966983; Model Number: DYNJ64372, UPC Number: 019348980722; Model Number: DYNJ64372A, UPC Number: 019348988468; Model Number: DYNJ68968, UPC Number: 019348987039.    ii. Model Number: CDS984329J, UPC Number: 088994286535.   jj. Model Number: DYNJ62197, UPC Number: 019348963300.   kk. Model Number: DYNJ45757F, UPC Number: 088827779258.   ll. Model Number: DYNJ46549J, UPC Number: 019348933778.   mm. Model Number: DYNJ35574A, UPC Number: 088438953806; Model Number: DYNJ54131, UPC Number: 088994246680.   nn. Model Number: DYNJ60698B, UPC Number: 019532706789.   oo. Model Number: DYNJ63155A, UPC Number: 019348931402.   pp. Model Number: DYNJ42172A, UPC Number: 019348950271.   qq. Model Number: DYNJ58225B, UPC Number: 088827777898.   rr. Model Number: PHS479840M, UPC Number: 019348968272.   ss. Model Number: MNS11625, UPC Number: 065316032213.   tt. Model Number: DYNJ41114B, UPC Number: 088994269269.   uu. Model Number: DYNJRA1256, UPC Number: 019348951155.   vv. Model Number: DYNJ57149, UPC Number: 088994272160; Model Number: DYNJ67899, UPC Number: 019348945449.   ww. Model Number: DYNJ40379C, UPC Number: 088994281455.   xx. Model Number: DYNJ906112, UPC Number: 019348965663.   yy. Model Number: DYNJ60009A, UPC Number: 019348964887.   zz. Model Number: DYNJ905826B, UPC Number: 019348978095; Model Number: DYNJ905826C, UPC Number: 019348940758; Model Number: DYNJ905826D, UPC Number: 019532702352; Model Number: DYNJ905826F, UPC Number: 019532721705.   aaa. Model Number: DYNJ33546J, UPC Number: 019348956435.   bbb. Model Number: DYNJ0785821M, UPC Number: 019348956435; Model Number: DYNJ0785821N, UPC Number: 019348956435; Model Number: DYNJ0785821O, UPC Number: 019532726373.   ccc. Model Number: DYNJ62434A, UPC Number: 019348936627.   ddd. Model Number: DYNJ0369434M, UPC Number: 019532729542.   eee. Model Number: CDS984584L, UPC Number: 088994270130.   fff. Model Number: DYNJ53135B, UPC Number: 019348966082; Model Number: DYNJ53135C, UPC Number: 019348946843.   ggg. Model Number: DYNJ0416535U, UPC Number: 019348956435; Model Number: DYNJ0416535Y, UPC Number: 019348956435.   hhh. Model Number: DYNJ67504A, UPC Number: 019532700961.   iii. Model Number: DYNJ57303A, UPC Number: 088827778321; Model Number: DYNJ57303B, UPC Number: 019348936064.   jjj. Model Number: DYNJ64027, UPC Number: 019348977993.   kkk. Model Number: DYNJ49833J, UPC Number: 019532705946.   lll. Model Number: DYNDA2805, UPC Number: 019348984614.   mmm. Model Number: DYNJRA0958, UPC Number: 088994261890.   nnn. Model Number: DYNJ48153C, UPC Number: 088994276562.   ooo. Model Number: DYNJ43777G, UPC Number: 088994291573.   ppp. Model Number: DYNJ63339A, UPC Number: 019348929531; Model Number: DYNJ63339B, UPC Number: 019348984061.   qqq. Model Number: DYNJ53319C, UPC Number: 019348963449.   rrr. Model Number: DYNJ63340, UPC Number: 019348974116.   sss. Model Number: DYNJ906391B, UPC Number: 019348981688.   ttt. Model Number: DYNDH1190, UPC Number: 088994249424.   uuu. Model Number: DYKM2125, UPC Number: 019532704487.   vvv. Model Number: DYNJ58424, UPC Number: 088994285183.   www. Model Number: DYNJ37099C, UPC Number: 019348956435.   xxx. Model Number: DYNJ59062, UPC Number: 088994294165.   yyy. Model Number: TVS4300A, UPC Number: 081698202335.   zzz. Model Number: TVS4500A, UPC Number: 081698202337; Model Number: TVS4500B, UPC Number: 019532722356.   aaaa. Model Number: ULT2175B, UPC Number: 019348958303; Model Number: ULT2175C, UPC Number: 10653160344353.   bbbb. Model Number: DYNDV2537, UPC Number: 019532718408.   cccc. Model Number: DYNDC2099, UPC Number: 088827729567.   dddd. Model Number: DYNJ56535, UPC Number: 088994265334.   eeee. Model Number: DYNDH1319, UPC Number: 088994279547.   ffff. Model Number: DYNDV2385A, UPC Number: 019532729876.   gggg. Model Number: IVS3485A, UPC Number: 065316099015; Model Number: IVS3840A, UPC Number: 019348947673.   hhhh. Model Number: DYNDV2038B, UPC Number: 019348991983; Model Number: IVS3300, UPC Number: 065316030766; Model Number: IVS3495A, UPC Number: 065316099305.   iiii. Model Number: IVS3820, UPC Number: 065316034231.   jjjj. Model Number: DYNDV2371, UPC Number: 019348943086.   kkkk. Model Number: DYNJ56507B, UPC Number: 019348944347; Model Number: DYNJ64930, UPC Number: 019348923168.   llll. Model Number: DYNDH1112, UPC Number: 10889942277360.   mmmm. Model Number: IV8635D, UPC Number: 065316099026.   nnnn. Model Number: DYNDV2502, UPC Number: 019532701409.   oooo. Model Number: DYNDH1204, UPC Number: 088994251983; Model Number: DYNDH1468A, UPC Number: 019348944003; Model Number: DYNJRA0389, UPC Number: 088438972552; Model Number: DYNDH1204, UPC Number: 10889942519835.   pppp. Model Number: DYNJ61433, UPC Number: 019348956517.   qqqq. Model Number: DYNJ60006A, UPC Number: 019348981007.   rrrr. Model Number: DYNJ51638B, UPC Number: 019348994641; Model Number: DYNJ51638C, UPC Number: 019532703956.   ssss. Model Number: DYNDH1492, UPC Number: 019348943446.   tttt. Model Number: DYNJ904401B, UPC Number: 019348968343.   uuuu. Model Number: DYNJ902259A, UPC Number: 088994225654.   vvvv. Model Number: CDS982895I, UPC Number: 088994220768.   wwww. Model Number: DYNJ902261D, UPC Number: 088994275524.   xxxx. Model Number: DYNJ43593A, UPC Number: 088994225559; Model Number: DYNJ53475D, UPC Number: 019348954775.   yyyy. Model Number: VC-PK, UPC Number: 019532717689.   zzzz. Model Number: DYNJ63268B, UPC Number: 019348930511; Model Number: DYNJ66079, UPC Number: 019348931744.  aaaaa. Model Number: DYNJ61148A, UPC Number: 019348954925.   bbbbb. Model Number: DYNJ32397B, UPC Number: 088438991665; Model Number: DYNJ54139A, UPC Number: 088994256499; Model Number: DYNJ59094, UPC Number: 088994293350; Model Number: DYNJ65189C, UPC Number: 019532707200.   ccccc. Model Number: DYNJS3005, UPC Number: 088438909956.   ddddd. Model Number: DYNJ55841B, UPC Number: 088827775768.   eeeee. Model Number: DYNJ64190A, UPC Number: 019348943563.   fffff. Model Number: DYNJ0309084D, UPC Number: 088994288526; Model Number: DYNJ38682C, UPC Number: 088994289719; Model Number: DYNJ51248B, UPC Number: 088994287340; Model Number: DYNJ59662A, UPC Number: 019348954814; Model Number: DYNJ59681, UPC Number: 088827777552; Model Number: DYNJ61264, UPC Number: 019348955447.   ggggg. Model Number: DYNJ59631, UPC Number: 088827776402.   hhhhh. Model Number: DYNDA2076, UPC Number: 088994270850.   iiiii. Model Number: DYNJ38264C, UPC Number: 019348956435.   jjjjj. Model Number: DYNJ57736A, UPC Number: 088827777970.   kkkkk. Model Number: DYNJ59751A, UPC Number: 019348959856.   lllll. Model Number: DYNJ20094J, UPC Number: 019348956435; Model Number: DYNJ20094K, UPC Number: 019348956435.   mmmmm. Model Number: DYNJ56260B, UPC Number: 019348956982.   nnnnn. Model Number: DYNJ64666A, UPC Number: 019348931726.   ooooo. Model Number: DYNJ901392D, UPC Number: 019348953951.   ppppp. Model Number: DYNJ59246, UPC Number: 088827776729.   qqqqq. Model Number: DYNJ53349A, UPC Number: 088994257453.   rrrrr. Model Number: DYNJ35988G, UPC Number: 019348956435; Model Number: DYNJ35988I, UPC Number: 019348956435; Model Number: DYNJ35988J, UPC Number: 019532702466.   sssss. Model Number: DYNJ56392, UPC Number: 088994264067; Model Number: DYNJ56392A, UPC Number: 019532726140."
    }
  ]
}