{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Temple Terrace",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93656",
      "recalling_firm": "American Contract Systems, Inc.",
      "address_1": "7802 E Telecom Pkwy",
      "address_2": "",
      "postal_code": "33637-0928",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-0818-2024",
      "product_description": "Procedural convenience kits and trays, cardiac, labeled as:    a)\tEP LAB BI V IMPLANT PACK, kit number AGBI64J;   b)\tLAB DEVICE IMPLANT, kit number AGDI40J;   c)\tLAB DEVICE IMPLANT, kit number AGDI40K;   d)\tMINOR VASCULAR, kit number AGMV26O;   e)\tOPEN HEART ACCESSORY, kit number AGOH98Q;   f)\tOPEN HEART ACCESSORY, kit number AGOH98R;   g)\tOPEN HEART ACCESSORY, kit number AGOH98S;   h)\tPERIPHERAL VASCULAR, kit number AGPV28O;   i)\tPERIPHERAL VASCULAR, kit number AGPV28P;   j)\tMINOR VASCULAR, kit number AHMV26J;   k)\tMINOR VASCULAR, kit number AHMV26K;   l)\tHEART PACK - 205947, kit number ANCV78AX;   m)\tHEART PACK - 205947 , kit number ANCV78AX1;   n)\tHEART PACK - 205947 Post Open-Heart, kit number ANHK74N;   o)\tOPEN HEART EAST PACK, kit number BHOH43;   p)\t74OFF PUMP CABG PACK, kit number BHOP48;   q)\tPACEMAKER PACK, kit number BHPM60;   r)\tFORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K;   s)\tT AND A PACK AGH ASC, kit number FBDI42L;   t)\tT AND A PACK AGH ASC, kit number FBDI42M;   u)\tTHORACOSCOPY PACK, kit number FBTO60G;   v)\tOPEN HEART ACCESSORY PACK, kit number JROH00O;   w)\tOPEN HEART ACCESSORY PACK, kit number JROH98O;   x)\tADULT OPEN HEART PACK, kit number LLOH52;   y)\tADULT OPEN HEART PACK, kit number LLOP25;   z)\tPACEMAKER PACK, kit number LLPP14;   aa)\tHEART PACK, kit number LMCB06AD;   bb)\tCARDIAC HEART BUNDLE NS, kit number LMCH99O;   cc)\tOPEN HEAART PACK, kit number LMOH50AD;   dd)\tOPEN HEAART PACK, kit number LMOH50AD-01;   ee)\tOPEN HEAART PACK, kit number LMOH50AD-02;   ff)\tOPEN HEAART PACK, kit number LMOH50AE;   gg)\tCV PACK, kit number MMCV98V;   hh)\tCV PACK, kit number MMCV98V-03;   ii)\tCV PACK, kit number MMCV98V-04;   jj)\tKIT OPEN HEART ADULT, kit number MMOH64J;   kk)\tPACEMAKER PACK, kit number MMPM27E;   ll)\tKIT, THORACOTOMY UNIVERSAL, kit number MMTR12F;   mm)\tANT CERV FUSION PACK, kit number NCAC96;   nn)\tOPEN HEART- ACCESSOR, kit number NCOH11;   oo)\tVASCULAR SAH, kit number SAVA91G;   pp)\tVASCULAR SAH, kit number SAVA91H;   qq)\tVASCULAR SAH, kit number SAVA91I;   rr)\tVASCULAR SAH, kit number SAVA91J;   ss)\tOPEN HEART BRINGBACK SJH, kit number SJOH17I;   tt)\tOPEN HEART CV SJH, kit number SJOH28L;   uu)\tPEDIATRIC HEART SJH, kit number SJPH34K;   vv)\tVASC OPEN CVOR SJH, kit number SJVO56A;   ww)\tVASC OPEN CVOR SJH, kit number SJVO56B;   xx)\tMAJOR CV TRAY, kit number SVMJ20L;   yy)\tMAJOR CV TRAY, kit number SVMJ20M;   zz)\tMINOR CV TRAY¿, kit number SVMN60J;   aaa)\tOPEN HEART COMPONENT PACK, kit number SVOH38Q;   bbb)\tCV B PACK, kit number TNCB10AK;   ccc)\tCARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM",
      "product_quantity": "12291 units",
      "reason_for_recall": "During an internal investigation, ACS identified that several components were \"piggybacked\" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the \"piggybacked\" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the  piggybacked  components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.",
      "recall_initiation_date": "20231129",
      "center_classification_date": "20240126",
      "report_date": "20240207",
      "code_info": "a) AGBI64J, UDI/DI 0019107247578, Lot numbers:  956231, exp. 2/13/2024; 674221, exp. 11/22/2023; 699221, exp. 10/28/2023; 727221, exp. 9/30/2023; 731221, exp. 9/26/2023; 769221, exp. 8/19/2023; 876221, exp. 5/4/2023;   b) AGDI40J, UDI/DI 00191072154668, Lot numbers:  956231, exp. 7/31/2023; 647221, exp. 7/31/2023; 708221, exp. 7/31/2023; 750221, exp. 7/31/2023;  c) AGDI40K, UDI/DI 00191072188168, Lot numbers:  910231, exp. 3/31/2024; 904231, exp. 4/6/2024;  d) AGMV26O, UDI/DI 00191072179777, Lot numbers:  900231, exp. 2/23/2024; 912231, exp. 2/23/2024; 949231, exp. 2/20/2023; 982231, exp. 1/18/2024; 666221, exp. 11/30/2023; 713221, exp. 10/14/2023; 763221, exp. 8/25/2023; 822221, exp. 6/27/2023; e) AGOH98Q, UDI/DI 00191072159419, Lot numbers:  846221, exp. 6/3/2023;  f) AGOH98R, UDI/DI 00191072169754, Lot numbers: 742221, exp. 9/15/2023; 772221, exp. 8/16/2023; 794221, exp. 7/25/2023;   g) AGOH98S, UDI/DI 00191072179784, Lot numbers:  921231, exp. 7/31/2023; 636221, exp. 10/10/2023; 685221, exp. 11/11/2023; 707221, exp. 7/31/2023; 729221, exp. 7/31/2023; h) AGPV28O, UDI/D I00191072137210, Lot numbers:  847221, exp. 6/2/2023;  i) AGPV28P, UDI/DI 00191072179791, Lot numbers:  771221, exp. 8/17/2023; 961231, exp. 2/8/2024; 696221, exp. 10/31/2023;  j) AHMV26J, UDI/DI 00191072137586, Lot numbers:  735221, exp. 9/22/2023; 790221, exp. 7/29/2023; 839221, exp. 6/10/2023;  k) AHMV26K, UDI/DI 00191072179807, Lot numbers:  896231, exp. 4/14/2024; 977231, exp. 1/23/2024; 953231, exp. 2/16/2024; 969231, exp. 1/31/2024; 686221, exp. 11/10/2023; 721221, exp. 10/6/2023;  l) ANCV78AX, UDI/DI 00191072182692, Lot numbers: 706221, exp. 10/21/2023;  m) ANCV78AX1, UDI/DI 00191072182692, Lot numbers:  647221, exp. 12/19/2023;  n) ANHK74N, UDI/DI 00191072191472, Lot numbers:  706221, exp. 10/21/2023;  o) BHOH43, UDI/DI 00191072160690, Lot numbers:  960231, exp. 2/9/2023; 668221, exp. 11/28/2023; 734221, exp. 9/23/2023; 773221, exp. 8/15/2023; 828221, exp. 6/21/2023; 876221, exp. 5/4/2023; 902221, exp. 4/8/2023;  p) BHOP48, UDI/DI 00191072164131, Lot numbers:  921231, exp. 3/20/2024; 948231, exp. 2/21/2024; 984231, exp. 1/16/2024; 783221, exp. 8/5/2023; 688221, exp. 1/8/2023; 736221, exp. 9/12/2023; 833221, exp. 6/16/2023; 867221, exp. 5/13/2023; 903221, exp. 4/7/2023;  q) BHPM60, UDI/DI 00191072160799, Lot numbers:  928231, exp. 3/13/2024; 968231, exp. 2/1/2024; 651221, exp. 12/15/2023; 702221, exp. 10/25/2023; 762221, exp. 8/26/2023; 836221, exp. 6/13/2023; 883221, exp. 4/27/2023;  r) FBDI42K, UDI/DI 00191072169761, Lot numbers:  976231, exp. 7/31/2023; 644221, exp. 7/31/2023; 678221, exp. 7/31/2023; 716221, exp. 7/31/2023; 743221, exp. 7/31/2023; 758221, exp. 7/31/2023; 828221, exp. 6/21/2023; 846221, exp. 6/3/2023;  s) FBDI42L, UDI/DI 00191072189905, Lot numbers:  920231, exp. 7/31/2023; 942231, exp. 7/31/2023;  t) FBDI42M, UDI/DI 00191072192066, Lot numbers:  899231, exp. 4/11/2024;  u) FBTO60G, UDI/DI 00191072164219, Lot numbers:  654221, exp. 12/12/2023; 689221, exp. 11/7/2023;  v) JROH00O, UDI/DI 00191072179814, Lot numbers:  906231, exp. 4/4/2024; 932231, exp. 3/9/2024; 935231, exp. 8/21/2023; 968231, exp. 2/1/2024; 988231, exp. 12/9/2023;  w) JROH98O, UDI/DI 00191072179821, Lot numbers:  900231, exp. 4/10/2024; 657221, exp. 11/18/2023; 686221, exp. 10/14/2023; 713221, exp. 9/14/2023;  x) LLOH52, UDI/DI 00191072169785, Lot numbers:  729221, exp. 9/28/2023; 722221, exp. 10/5/2023; 668221, exp. 11/28/2023; 980231, exp. 1/20/2024; 903231, exp. 4/7/2024;  y) LLOP25, UDI/DI 00191072167347, Lot numbers:  766221, exp. 8/22/2023; 729221, exp. 9/28/2023;  z) LLPP14, UDI/DI 00191072167354, Lot numbers:  741221, exp. 9/16/2023; 695221, exp. 11/1/2023; 639221, exp. 12/27/2023; 940231, exp. 3/1/2024;  aa) LMCB06AD, UDI/DI none, Lot numbers: 721221, exp. 10/6/2023; 675221, exp. 11/21/2023; 927231, exp. 3/14/2024; 890231, exp. 4/20/2024;   bb) LMCH99O, UDI/DI none, Lot numbers:  762221, exp. 8/26/2023; 715221, exp. 10/12/2023; 674221, exp. 11/22/2023; 872231, exp. 5/8/2024;  cc) LMOH50AD, UDI/DI 00191072165534, Lot numbers:  847221, exp. 6/2/2023; 833221, exp. 6/16/2023; 807221, exp. 7/12/2023; 751221, exp. 8/27/2023;  dd) LMOH50AD-01, UDI/DI 0019107216553 , Lot numbers:  878221, exp. 5/2/2023; 765221, exp. 8/23/2023;  ee) LMOH50AD-02, UDI/DI 00191072165534, Lot numbers:  731221, exp. 9/26/2023; 682221, exp. 11/14/2023;  ff) LMOH50AE, UDI/DI 00191072184443, Lot numbers:  973231, exp. 1/27/2024;  gg) MMCV98V, UDI/DI 00191072155481, Lot numbers:  867221, exp. 5/13/2023; 828221, exp. 6/21/2023; 949231, exp. 2/20/2024;  hh) MMCV98V-03, UDI/DI 00191072155481, Lot numbers:  783221, exp. 8/5/2023;  ii) MMCV98V-04, UDI/DI 00191072155481, Lot numbers:  681221, exp. 11/15/2023;  jj) MMOH64J, UDI/DI none, Lot numbers:  933231, exp. 3/8/2024; 871231, exp. 5/9/2024;  kk) MMPM27E, UDI/DI none, Lot numbers:  935231, exp. 3/6/2024;  ll) MMTR12F, UDI/DI none, Lot numbers:  889231, exp. 4/21/2024;  mm) NCAC96, UDI/DI 00191072016829, Lot numbers:  963231, exp. 8/18/2023; 996231, exp. 6/2/2023; 715221, exp. 6/2/2023; 811221, exp. 6/2/2023; 863221, exp. 5/17/2023;  nn) NCOH11, UDI/DI 00191072160867, Lot numbers:  956231, exp. 2/13/2024; 674221, exp. 11/22/2023; 751221, exp. 4/6/2023; 827221, exp. 6/22/2023; 864221, exp. 5/16/2023;  oo) SAVA91G, UDI/DI none, Lot numbers:  824221, exp. 6/25/2023; 870221, exp. 5/10/2023;  pp) SAVA91H, UDI/DI none, Lot numbers:  790221, exp. 7/29/2023;  qq) SAVA91I, UDI/DI none, Lot numbers:  702221, exp. 10/25/2023; 742221, exp. 9/15/2023;  rr) SAVA91J, UDI/DI none, Lot numbers:  667221, exp. 10/31/2023; 946231, exp. 2/23/2024; 989231, exp. 1/11/2024;  ss) SJOH17I, UDI/DI none, Lot numbers:  696221, exp. 10/31/2023; 747221, exp. 9/10/2023; 778221, exp. 8/10/2023; 817221, exp. 7/2/2023; 863221, exp. 5/17/2023; 988231, exp. 1/12/2024;  tt) SJOH28L, UDI/DI none, Lot numbers:  650221, exp. 12/16/2023; 702221, exp. 10/25/2023; 744221, exp. 9/13/2023; 792221, exp. 7/27/2023; 838221, exp. 6/11/2023; 888221, exp. 4/22/2023; 961231, exp. 2/8/2024; 918231, exp. 3/23/2024;  uu) SJPH34K, UDI/DI none, Lot numbers:  678221, exp. 11/18/2023; 750221, exp. 9/7/2023; 818221, exp. 7/1/2023; 975231, exp. 1/25/2024;  vv) SJVO56A, UDI/DI none, Lot numbers:  763221, exp. 8/25/2023;  ww) SJVO56B, UDI/DI none, Lot numbers:  636221, exp. 12/30/2023; 661221, exp. 12/5/2023; 686221, exp. 11/10/2023; 707221, exp. 10/20/2023; 911231, exp. 3/30/2024; 940231, exp. 3/1/2024; 974231, exp. 1/26/2024;  xx) SVMJ20L, UDI/DI 00191072142405, Lot numbers:  737221, exp. 9/20/2023; 807221, exp. 7/12/2023; 863221, exp. 5/17/2023;  yy) SVMJ20M, UDI/DI 00191072179838, Lot numbers:  903231, exp. 4/7/2024; 955231, exp. 2/14/2024; 681221, exp. 11/15/2023;  zz) SVMN60J, UDI/DI 00191072142412, Lot numbers:  654221, exp. 12/12/2023; 734221, exp. 9/23/2023; 784221, exp. 8/4/2023; 836221, exp. 6/13/2023;  aaa) SVOH38Q, UDI/DI 00191072156488, Lot numbers:  913231, exp. 3/28/2024; 891231, exp. 4/19/2024; 953231, exp. 2/16/2024; 961231, exp. 2/8/2024; 637221, exp. 12/29/2023; 651221, exp. 12/15/2023; 710221, exp. 10/17/2023; 729221, exp. 9/28/2023; 784221, exp. 7/31/2023;  bbb) TNCB10AK, UDI/DI 00191072184948, Lot numbers:  995231, exp. 1/5/2024;  ccc)  UICD62AM, UDI/DI none, Lot numbers:  959231, exp. 2/10/2024; 879231, exp. 5/1/2024",
      "more_code_info": ""
    }
  ]
}