{
  "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-2300-2023",
      "product_description": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. AAA PACK, Model Number: DYNJ44847I;    b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578;   c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C;   d. ABLATION PACK, Model Number: DYNJ61957A;   e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F;   f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M;   g. AFIB PACK, Model Number: DYNJ69682;   h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   i. ANGIO-VASCULAR, Model Number: DYNJ24272C;   j. ARM VASCULAR-LF, Model Number: DYNJ905290D;   k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038;   l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A;   m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051;   n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D;   o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C;   p. AV FIST PACK, Model Number: DYNJ83462;   q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096;   r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570;   s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477;   t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C;   u. AV FISTULA VASCULAR, Model Number: DYNJ67340;   v. AV GRAFT, Model Number: DYNJ903457D;   w. AV GRAFT-LF, Model Number: DYNJ40077F;   x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I;   y. BEDSIDE PICC CDS, Model Number: CDS984642;   z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339;   aa. C V MAJOR PACK, Model Number: DYNJ64861A;   bb. C V MINOR PACK, Model Number: DYNJ64862B;   cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G;   dd. CABG HEART CDS, Model Number: CDS985384C;   ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F;   ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A;   gg. CARDIAC A  B PACK-LF, Model Number: DYNJV0177AG;   hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG;   ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B;   jj. CARDIAC CABG PACK, Model Number: DYNJ903072R;   kk. CARDIAC CATH PACK, Model Number: DYNJ41195D;   ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M;   mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A;   nn. CARDIOLOGY EP, Model Number: DYNJ59968;   oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F;   pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D;   qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A;   rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A;   ss. CAROTID PACK-LF, Model Number: DYNJ57646C;   tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369;   uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F;   vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K;   ww. CATH LAB PACK, Model Number: DYNJ57735F;   xx. CATH PACK, Model Number: DYNJ59830A;   yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A;   zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G;    aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I;   bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C;   ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A;   ddd. CV CDS, Model Number: CDS985395D;   eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432;   fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A;   ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D;   hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C;   iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   kkk. DBD-AV FISTUL",
      "product_quantity": "46,124 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: DYNJ44847I, UPC Number: 019532712755.  b. Model Number: DYNJ82578, UPC Number: 019532719814.  c. Model Number: DYNJ905291B, UPC Number: 019348995037; Model Number: DYNJ905291C, UPC Number: 019532706254.  d. Model Number: DYNJ61957A, UPC Number: 019348969907.  e. Model Number: DYNJ36600F, UPC Number: 088994255256.   f. Model Number: DYNJV0275J, UPC Number: 019348926312; Model Number: DYNJV0275K, UPC Number: 019348926312; Model Number: DYNJV0275L, UPC Number: 019348926312; Model Number: DYNJV0275M, UPC Number: 019532701862.   g. Model Number: DYNJ69682, UPC Number: 019348996892.  h. Model Number: CDS840493F, UPC Number: 019348964363.  i. Model Number: DYNJ24272C, UPC Number: 019348962022.   j. Model Number: DYNJ905290D, UPC Number: 019532706253.  k. Model Number: DYNDC3038, UPC Number: 019348949360.  l. Model Number: DYNJ81636, UPC Number: 019532712918; Model Number: DYNJ81636A, UPC Number: 019532724491.  m. Model Number: DYNJ83051, UPC Number: 019532724528.  n. Model Number: DYNJ40728D, UPC Number: 019532734836.   o. Model Number: DYNJ40728A, UPC Number: 088827704690; Model Number: DYNJ40728B, UPC Number: 019348997028; Model Number: DYNJ40728C, UPC Number: 019532703746.   p. Model Number: DYNJ83462, UPC Number: 019532726814.  q. Model Number: DYNJ64143B, UPC Number: 019532727958; Model Number: DYNJ905219B, UPC Number: 019348992403; Model Number: DYNJ905219C, UPC Number: 019532712693; Model Number: DYNJ905219D, UPC Number: 019532715487; Model Number: DYNJ905219F, UPC Number: 019532733532; Model Number: DYNJ906341D, UPC Number: 019532702148; Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975, UPC Number:019348996560; Model Number: DYNJ907975B, UPC Number: 019532737629; Model Number: DYNJ908096, UPC Number: 019348997407.  r. Model Number: DYNJ82570, UPC Number: 019532719806.  s. Model Number: DYNJ52093J, UPC Number: 019348998856; Model Number: DYNJ62218B, UPC Number: 019348996016; Model Number: DYNJ66184A, UPC Number: 019348991193; Model Number: DYNJ66184B, UPC Number: 019532703433; Model Number: DYNJ67178A, UPC Number: 019532702787; Model Number: DYNJ69443A, UPC Number: 019532702654; Model Number: DYNJ69443B, UPC Number: 019532708906; Model Number: DYNJ69443D, UPC Number: 019532727023; Model Number: DYNJ69489A, UPC Number: 019532722704; Model Number: DYNJ81033, UPC Number: 019532708298; Model Number: DYNJ81605, UPC Number: 019532712388; Model Number: DYNJ82477, UPC Number: 019532719722.  t. Model Number: DYNJ64499B, UPC Number: 019348996109; Model Number: DYNJ64499, UPC Number: 019532722644; Model Number: DYNJ69167A, UPC Number: 019532708351; Model Number: DYNJ69167C, UPC Number: 019532734312.  u. Model Number: DYNJ67340, UPC Number: 019348990107.  v. Model Number: DYNJ903457D, UPC Number: 019348967091.  w.  Model Number: DYNJ40077F, UPC Number: 019532717581.  x. Model Number: CDS983147F, UPC Number: 019348963379; Model Number: CDS983147I, UPC Number: 019532707551.  y. Model Number: CDS984642, UPC Number: 088438988292.  z. Model Number: DYNJ907339, UPC Number: 019348939732.  aa. Model Number: DYNJ64861A, UPC Number: 019532705363.  bb.  Model Number: DYNJ64862B, UPC Number: 019532705370.  cc. Model Number: DYNJ906878A, UPC Number: 019348939130; Model Number: DYNJ9372030F, UPC Number: 019348966807; Model Number: DYNJ9372030G, UPC Number: 019532702543.  dd. Model Number: CDS985384C, UPC Number: 088994296218.  ee. Model Number: DYNJ0408782AA, UPC Number: 019532711581; Model Number: DYNJ53827, UPC Number: 088994244401; Model Number: DYNJ59036B, UPC Number: 019348967227; Model Number: DYNJ59036C, UPC Number: 019348988162; Model Number: DYNJ59036D, UPC Number: 019532700347; Model Number: DYNJ59036F, UPC Number: 019532727293.  ff. Model Number: DYNJ68389, UPC Number: 019348944114; Model Number: DYNJ68389A, UPC Number: 019348991219.  gg. Model Number: DYNJV0177AG, UPC Number: 019532711235.  hh. Model Number: DYNJV0177AG, UPC Number: 019532711235.   ii. Model Number: DYNJ908121A, UPC Number: 019532700057; Model Number: DYNJ908121B, UPC Number: 019532709571.   jj. Model Number: DYNJ903072R, UPC Number: 019348983405.  kk. Model Number: DYNJ41195D, UPC Number: 019348931425.  ll. Model Number: DYNJ0429185K, UPC Number: 019348956435; Model Number: DYNJ0429185M, UPC Number: 019532737135.  mm. Model Number: DYNJ66254A, UPC Number: 019348981897.  nn. Model Number: DYNJ59968, UPC Number: 088827779132.  oo. Model Number: DYNJ905516C, UPC Number: 019348996712; Model Number: DYNJ905516D, UPC Number: 019532714783; Model Number: DYNJ905516F, UPC Number: 019532724757.  pp. Model Number: DYNJ906351B, UPC Number: 019348981671; Model Number: DYNJ906351D, UPC Number: 019532716157.  qq. Model Number: DYNJ905640A, UPC Number: 019532703918.  rr. Model Number: DYNJ0810062AI, UPC Number: 019348956435; Model Number: DYNJ0810062AJ, UPC Number: 019532732546; Model Number: DYNJ39488G, UPC Number: 019348938377; Model Number: DYNJ66190A, UPC Number: 019348991300; Model Number: DYNJ66190B, UPC Number: 019532703432; Model Number: DYNJ66190C, UPC Number: 019532734200; Model Number: DYNJ80346A, UPC Number: 019532716625.  ss. Model Number: DYNJ57646C, UPC Number: 019532728713.   tt. Model Number: DYNJ81369, UPC Number: 019532711530.  uu. Model Number: DYNJ44927F, UPC Number: 019348976680.  vv. Model Number: CDS984764F, UPC Number: 088994296945; Model Number: DYNJ901745K, UPC Number: 019348948223.  ww. Model Number: DYNJ57735F, UPC Number: 019348962970.  xx. Model Number: DYNJ59830A, UPC Number: 019348957023.  yy. Model Number: DYNJ62379A, UPC Number: 019532719663.  zz. Model Number: DYNJC9258G, UPC Number: 019532724550.  aaa. Model Number: CDS983202F, UPC Number: 019348933525; Model Number: CDS983202G, UPC Number: 019348949077; Model Number: CDS983202I, UPC Number: 019532716467.  bbb. Model Number: DYNJ906108A, UPC Number: 019348944363; Model Number: DYNJ906108B, UPC Number: 019532704117; Model Number: DYNJ906108C, UPC Number: 019532711827.  ccc. Model Number: DYNJ65710A, UPC Number: 019348993865.  ddd. Model Number: CDS985395D, UPC Number: 019348985971.  eee. Model Number: DYNJ83432, UPC Number: 019532726653.  fff. Model Number: DYNJ64506A, UPC Number: 019348997106.  ggg. Model Number: DYNJ46359C, UPC Number: 088994253711; Model Number: DYNJ46359D, UPC Number: 019348996137.  hhh.  Model Number: DYNJ905291C, UPC Number: 019532706254.  iii. Model Number: CDS840493F, UPC Number: 019348964363.  jjj. Model Number: CDS840493F, UPC Number: 019348964363.   kkk. Model Number: DYNJ906945A, UPC Number: 019532712825; Model Number: DYNJ907975A, UPC Number: 019532715507.  lll. Model Number: DYNJ69443C, UPC Number: 019532712973.  mmm. Model Number: DYNJ57646B, UPC Number: 019348982850.  nnn. Model Number: DYNJ64964B, UPC Number: 019532707581.  ooo. Model Number: DYNJ59028A, UPC Number: 019348973659.  ppp. Model Number: DYNJ907552A, UPC Number: 019532716605.  qqq. Model Number: DYNJ56904, UPC Number: 088994269345.  rrr. Model Number: DYNJ63209, UPC Number: 019348972788.    sss. Model Number: DYNJ67487B, UPC Number: 019532716614.  ttt. Model Number: DYNJ905495F, UPC Number: 019348992493.  uuu. Model Number: DYKMBNDL22B, UPC Number: 019532705026.  vvv. Model Number: DYNJ905884A, UPC Number: 019348979544.  www. Model Number: DYNJ81610, UPC Number: 019532712394.  xxx. Model Number: DYNJ54286A, UPC Number: 088994276549.  yyy. Model Number: CDS984241M, UPC Number: 019532716563.  zzz. Model Number: DYNJ23697N, UPC Number: 019348949845.  aaaa. Model Number: DYNJ55836B, UPC Number: 019348995117.   bbbb. Model Number: DYNJ63341C, UPC Number: 019532708612.   cccc. Model Number: DYNJ48365, UPC Number: 088827759459.   dddd. Model Number: DYNJ69422, UPC Number: 019348993754.   eeee. Model Number: DYNJ905744C, UPC Number: 019532716231.   ffff. Model Number: CDS984764G, UPC Number: 019348945029.   gggg. Model Number: DYNJ81642, UPC Number: 019532712966.   hhhh. Model Number: DYNJ68404A, UPC Number: 019348991392.   iiii. Model Number: DYNJ65048, UPC Number: 019348924286.   jjjj. Model Number: DYNJ43085A, UPC Number: 019348960034.   kkkk. Model Number: DYNJ64261A, UPC Number: 019348932556.   llll. Model Number: DYNJ42976, UPC Number: 088827701914.   mmmm. Model Number: DYNJ907914, UPC Number: 019348994367; Model Number: DYNJ907914A, UPC Number: 019532714952; Model Number: DYNJ907914B, UPC Number: 019532718060; Model Number: DYNJ907914C, UPC Number: 019532732943.   nnnn. Model Number: DYNJ57595A, UPC Number: 019348962215.   oooo. Model Number: DYNJ0037939B, UPC Number: 019532703127.   pppp. Model Number: DYNJ52024, UPC Number: 088994223335.   qqqq. Model Number: DYNJ51968D, UPC Number: 019348967831.   rrrr. Model Number: DYNJ56235, UPC Number: 088994262155.   ssss. Model Number: DYNJ61247, UPC Number: 019348955170.   tttt. Model Number: DYNJ907552A, UPC Number: 019532716605.   uuuu. Model Number: DYNJ67517A, UPC Number: 019348946219.   vvvv. Model Number: PHS41732B, UPC Number: 019348978481.   wwww. Model Number: DYNJ55669C, UPC Number: 019348944785; Model Number: DYNJ55669D, UPC Number: 019532701301.   xxxx. Model Number: DYNJ57449C, UPC Number: 019348947184; Model Number: DYNJ57449D, UPC Number: 019348987229; Model Number: DYNJ57449F, UPC Number: 019348993920; Model Number: DYNJ57449G, UPC Number: 019532706488.   yyyy. Model Number: DYNJ49931I, UPC Number: 019348993921.   zzzz. Model Number: DYNJ54803B, UPC Number: 019348963378; Model Number: DYNJ54803C, UPC Number: 019348920261."
    }
  ]
}