{
  "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": "Mentor",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93566",
      "recalling_firm": "Steris Corporation",
      "address_1": "5960 Heisley Rd",
      "address_2": "",
      "postal_code": "44060-1834",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution nationwide. Foreign distribution to Australia Canada China Hong Kong Italy Malaysia Netherlands New Zealand Singapore Thailand",
      "recall_number": "Z-0617-2024",
      "product_description": "Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and  ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors    Model #\tModel Description  2-8-001\tHU ZERO CHANNEL NO LT  2-8-010\tASSY, HOOK-UP, OLYMPUS  2-8-014\tHOOKUP, OPTIM LT  2-8-030\tASSY, HOOKUP, PENTAX-0K  2-8-040\tASSY, HKUP STORZ 0K  2-8-070\tASSY, HU VISION SCIENCE  2-8-112\tASSY, HOOKUP OLMPUS 1K  2-8-120\tASSY, HOOKUP FUJI 1K  2-8-210\tASSY, HOOK-UP OLYMPUS 2K  2-8-213\tASSY, HOOKUP, OLYMPUS-2K  2-8-218\tASSY HOOKUP OLY 2K  2-8-236\tASSY, HOOKUP FUJINON 2K  2-8-244\tASSY, HOOKUP, STORZ 2K  2-8-245\tASSY, HOOK-UP, STORZ 2K  2-8-246\tASSY, HKUP, PENTAX-2K  2-8-260\tASSY, HOOK-UP WOLF 2-K  2-8-280\tASSY HOOKUP  2-8-312\tASSY, HOOK-UP OLYMPUS-3K  2-8-330\tASSY, HOOK-UP, PENTAX-3K  2-8-332\tASSEMBLY, HOOK-UP, PENTAX  2-8-334\tASSEMBLY, HOOK-UP, PENTAX  2-8-335\tASSY, HOOKUP, OLYMPUS, 3K  2-8-336\tASSY,HKUP FUJI 70 BRONC  2-8-338\tASSY, HU, FUJI BRONCH U/S  2-8-421\tASSY, HOOKUP, FUJIFILM  2-8-428\tASSY, ED-580XX  2-8-431\tASSY, HOOKUP, PENTAX  2-8-432\tASSY, HOOK-UP, PENTAX  2-8-460\tHOOKUP, ASSY WOLF 4K  2-8-511\tASSY, HOOK-UP, OLY  2-8-513\tASSY HOOKUP OLY 4K ESOPHA  2-8-522\tASSY, FUJINON 4K-JET  2-8-523\tASSY, HKUP, FUJI 4K SER 5  2-8-526\tASSY, HOOKUP FUJI 4K+JET  2-8-527\tASSY, FUJI 700 NO FWJ  2-8-528\tHOOK, EI-580BT  2-8-534\tASSY, HOOK-UP, PEN-4K+JET  2-8-537\tASSY, HKUP, PTX90 4K+JET  2-8-539\tHOOK, PTX I20 FWJ  2-8-540\tASSY-HOOK-UP,STORZ,5K  2-8-611\tASSY, HOOK-UP, OLY  2-8-612\tASSY, HOOKUP, PENTAX  2-8-614\tASM HU OLY TGF-UC180J  2-8-617\tASSY, HKUP, OLY 2 BIOPSY  2-8-623\tASSY,HKUP,FUJI-5 4K+JET  2-8-625\tASSY, HOOKUP, EG-580UT  2-8-626\tASSY, HOOKUP, EG-580UR  2-8-627\tASSY, HKUP, FUJI 700 SER  2-8-634\tASSY, HOOKUP PENTAX DUAL  2-8-639\tHOOK, EG3X-J10  2-8-640\tASSY,HOOK-UP STORZ 6K  2-8-711\tASSY, HOOKUP, OLYMPUS 5K  2-8-718\tASSY, HOOKUP, OLY 160/180  2-8-740\tASSY, HOOK-UP, STORZ  2-8-811\tASSY HKUP OLY-ECHO+LIFT  2-8-901\tKIT TEE/TOE/RUS HU ADV+  5-8-010\tASSY, HOOKUP DBL LT  5-8-030\tASSY, HOOKUP  5-8-040\tASSY HOOKUP STORZ 0K DBL  5-8-050\tASSY, HOOKUP, DILATOR  5-8-112\tHOOKUP 2-SCOPE 1-K  5-8-190\tHOOK DBL, IS, ION  5-8-210\tASSY, HOOKUP  5-8-245\tHOOKUP KARLSTORZ-2K  2-8-001HAN\tHU ZERO CHANNEL NO LT  2-8-002HAN\tADVANTAGE TEST BLOCK  2-8-010HAN\tASSEMBLY, HOOK-UP,OLYMPUS  2-8-030HAN\tASSY,HOOKUP,PENTAX-OK  2-8-112HAN\tASSY, HOOK-UP OLYMPUS 1K  2-8-160HAN\tASSY, ADV HOOKUP, WOLF  2-8-210HAN\tASSY, HOOK-UP OLYMPUS 2K  2-8-213HAN\tASSY, HOOKUP, OLYMPUS-2K  2-8-218HAN\tASSY HOOKUP OLY 2K  2-8-245HAN\tASSY, HOOKUP, STORZ-2K  2-8-330HAN\tASSY, HOOK-UP, PENTAX-3K  2-8-334HAN\tASSEMBLY, HOOK-UP, PENTAX  2-8-335HAN\tASSY,HOOKUP,OLYMPUS  2-8-336HAN\tASSY,HKUP FUJI 70 BRONC  2-8-338HAN\tASSY, HU, FUJI BRONCH U/S  2-8-421HAN\tASSY, HOOKUP, FUJINON  2-8-428CAS\tHOOK, CAS, ED-580XX  2-8-428HAN\tHOOK, HAN, ED-580XX  2-8-431CAS\tASSY, CASSETTE, PENTAX  2-8-431HAN\tASSY, HOOK-UP, PENTAX  2-8-511HAN\tASSY, HOOK-UP, OLY  2-8-526HAN\tASSY, HOOKUP FUJI 4K+JET  2-8-536HAN\tHOOKUP,PENTAX,70ULT, 5K  2-8-537CAS\tASSY,CASS,PTX 90 4K+JET  2-8-537HAN\tASSY HKUP,PTX90 4K+JET  2-8-611HAN\tASSY, HOOK-UP, OLY  2-8-626CAS\tASSY, CASS, FUJINON 580UR  2-8-627HAN\tASSY, HAN, FUJI 700 SER  2-8-634CAS\tASSY,CASS PENTAX DUAL CH  2-8-634HAN\tASSY,HOOKUP PENTAX DUAL  2-8-640HAN\tASSY, HOOK-UP STORZ 6K  2-8-711HAN\tASSY, HOOKUP, OLYMPUS-5K  2-8-718HAN\tASSY,HOOK-UP, OLY 160/180  2-8-811HAN\tASSY HKUP OLY-ECHO W/LIFT  2-8-902H\tHU BLOCK ULTRASOUND PROBE  5-8-030HAN\tASSY, HOOKUP  5-8-050HAN\tASSY,HOOKUP, DILATOR  5-8-112HAN\tASSY, HOOKUP 2-SCOPE 1-K  5-8-244HAN\tASSY, HKUP 2K DBL",
      "product_quantity": "2545 US; 992 OUS",
      "reason_for_recall": "Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.",
      "recall_initiation_date": "20231113",
      "center_classification_date": "20231222",
      "report_date": "20240103",
      "code_info": "Products distributed between July 17 - September 27, 2023  Model # Model Description UDI 2-8-001 HU ZERO CHANNEL NO LT 00677964068515 2-8-010 ASSY, HOOK-UP, OLYMPUS 00677964068478 2-8-014 HOOKUP, OPTIM LT 00677964095177 2-8-030 ASSY, HOOKUP, PENTAX-0K 00677964071348 2-8-040 ASSY, HKUP STORZ 0K 00677964072284 2-8-070 ASSY, HU VISION SCIENCE 00677964094637 2-8-112 ASSY, HOOKUP OLMPUS 1K 00677964071300 2-8-120 ASSY, HOOKUP FUJI 1K 00677964102080 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 00677964068485 2-8-213 ASSY, HOOKUP, OLYMPUS-2K 00677964070648 2-8-218 ASSY HOOKUP OLY 2K 00677964072369 2-8-236 ASSY, HOOKUP FUJINON 2K 00677964072376 2-8-244 ASSY, HOOKUP, STORZ 2K 00677964071836 2-8-245 ASSY, HOOK-UP, STORZ 2K 00677964071195 2-8-246 ASSY, HKUP, PENTAX-2K 00677964084058 2-8-260 ASSY, HOOK-UP WOLF 2-K 00677964105951 2-8-280 ASSY HOOKUP 00677964073069 2-8-312 ASSY, HOOK-UP OLYMPUS-3K 00677964074400 2-8-330 ASSY, HOOK-UP, PENTAX-3K 00677964073816 2-8-332 ASSEMBLY, HOOK-UP, PENTAX 00677964091483 2-8-334 ASSEMBLY, HOOK-UP, PENTAX 00677964073830 2-8-335 ASSY, HOOKUP, OLYMPUS, 3K 00677964071263 2-8-336 ASSY,HKUP FUJI 70 BRONC 00677964091506 2-8-338 ASSY, HU, FUJI BRONCH U/S 00677964074141 2-8-421 ASSY, HOOKUP, FUJIFILM 00677964071270 2-8-428 ASSY, ED-580XX 00677964104923 2-8-431 ASSY, HOOKUP, PENTAX 00677964071706 2-8-432 ASSY, HOOK-UP, PENTAX 00677964072239 2-8-460 HOOKUP, ASSY WOLF 4K 00677964092756 2-8-511 ASSY, HOOK-UP, OLY 00677964066726 2-8-513 ASSY HOOKUP OLY 4K ESOPHA 00677964102394 2-8-522 ASSY, FUJINON 4K-JET 40677964025387 2-8-523 ASSY, HKUP, FUJI 4K SER 5 00677964074158 2-8-526 ASSY, HOOKUP FUJI 4K+JET 00677964071904 2-8-527 ASSY, FUJI 700 NO FWJ 00677964111648 2-8-528 HOOK, EI-580BT 40677964025394 2-8-534 ASSY, HOOK-UP, PEN-4K+JET 00677964073632 2-8-537 ASSY, HKUP, PTX90 4K+JET 00677964068492 2-8-539 HOOK, PTX I20 FWJ 40677964039827 2-8-540 ASSY-HOOK-UP,STORZ,5K 00677964091223 2-8-611 ASSY, HOOK-UP, OLY 00677964066719 2-8-612 ASSY, HOOKUP, PENTAX 00677964073571 2-8-614 ASM HU OLY TGF-UC180J 00677964101984 2-8-617 ASSY, HKUP, OLY 2 BIOPSY 00677964073427 2-8-623 ASSY,HKUP,FUJI-5 4K+JET 00677964091476 2-8-625 ASSY, HOOKUP, EG-580UT 00677964077678 2-8-626 ASSY, HOOKUP, EG-580UR 00677964077685 2-8-627 ASSY, HKUP, FUJI 700 SER 00677964083006 2-8-634 ASSY, HOOKUP PENTAX DUAL 00677964074189 2-8-639 HOOK, EG3X-J10 40677964006560 2-8-640 ASSY,HOOK-UP STORZ 6K 00677964074417 2-8-711 ASSY, HOOKUP, OLYMPUS 5K 00677964070662 2-8-718 ASSY, HOOKUP, OLY 160/180 00677964070655 2-8-740 ASSY, HOOK-UP, STORZ 00677964102479 2-8-811 ASSY HKUP OLY-ECHO+LIFT 00677964070624 2-8-901 KIT TEE/TOE/RUS HU ADV+ 00677964046926 5-8-010 ASSY, HOOKUP DBL LT 00677964071874 5-8-030 ASSY, HOOKUP 00677964094644 5-8-040 ASSY HOOKUP STORZ 0K DBL 00677964072772 5-8-050 ASSY, HOOKUP, DILATOR 00677964072963 5-8-112 HOOKUP 2-SCOPE 1-K 00677964072307 5-8-190 HOOK DBL, IS, ION 40677964025493 5-8-210 ASSY, HOOKUP 00677964080333 5-8-245 HOOKUP KARLSTORZ-2K 00677964102493 2-8-001HAN HU ZERO CHANNEL NO LT 00677964064739 2-8-002HAN ADVANTAGE TEST BLOCK 00677964046568 2-8-010HAN ASSEMBLY, HOOK-UP,OLYMPUS 00677964001802 2-8-030HAN ASSY,HOOKUP,PENTAX-OK 00677964037399 2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K 00677964001819 2-8-160HAN ASSY, ADV HOOKUP, WOLF 00677964037443 2-8-210HAN ASSY, HOOK-UP OLYMPUS 2K 00677964001826 2-8-213HAN ASSY, HOOKUP, OLYMPUS-2K 00677964001871 2-8-218HAN ASSY HOOKUP OLY 2K 00677964061707 2-8-245HAN ASSY, HOOKUP, STORZ-2K 00677964037511 2-8-330HAN ASSY, HOOK-UP, PENTAX-3K 00677964001970 2-8-334HAN ASSEMBLY, HOOK-UP, PENTAX 00677964001994 2-8-335HAN ASSY,HOOKUP,OLYMPUS 00677964037634 2-8-336HAN ASSY,HKUP FUJI 70 BRONC 00677964045387 2-8-338HAN ASSY, HU, FUJI BRONCH U/S 00677964053443 2-8-421HAN ASSY, HOOKUP, FUJINON 00677964037658 2-8-428CAS HOOK, CAS, ED-580XX 40677964024663 2-8-428HAN HOOK, HAN, ED-580XX 40677964024670 2-8-431CAS ASSY, CASSETTE, PENTAX 00677964002045 2-8-431HAN ASSY, HOOK-UP, PENTAX 00677964002052 2-8-511HAN ASSY, HOOK-UP, OLY 00677964002144 2-8-526HAN ASSY, HOOKUP FUJI 4K+JET 00677964053764 2-8-536HAN HOOKUP,PENTAX,70ULT, 5K 00677964044168 2-8-537CAS ASSY,CASS,PTX 90 4K+JET 00677964037801 2-8-537HAN ASSY HKUP,PTX90 4K+JET 00677964037818 2-8-611HAN ASSY, HOOK-UP, OLY 00677964002236 2-8-626CAS ASSY, CASS, FUJINON 580UR 00677964077661 2-8-627HAN ASSY, HAN, FUJI 700 SER 00677964089701 2-8-634CAS ASSY,CASS PENTAX DUAL CH 00677964054815 2-8-634HAN ASSY,HOOKUP PENTAX DUAL 00677964054808 2-8-640HAN ASSY, HOOK-UP STORZ 6K 00677964087097 2-8-711HAN ASSY, HOOKUP, OLYMPUS-5K 00677964037924 2-8-718HAN ASSY,HOOK-UP, OLY 160/180 00677964064777 2-8-811HAN ASSY HKUP OLY-ECHO W/LIFT 00677964053542 2-8-902H HU BLOCK ULTRASOUND PROBE 00677964061509 5-8-030HAN ASSY, HOOKUP 00677964046681 5-8-050HAN ASSY,HOOKUP, DILATOR 00677964040306 5-8-112HAN ASSY, HOOKUP 2-SCOPE 1-K 00677964051548 5-8-244HAN ASSY, HKUP 2K DBL 00677964045165",
      "more_code_info": ""
    }
  ]
}