{
  "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": "2026-09-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waukegan",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99553",
      "recalling_firm": "Cardinal Health 200, LLC",
      "address_1": "3651 Birchwood Dr",
      "address_2": "N/A",
      "postal_code": "60085-8337",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-3101-2026",
      "product_description": "Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:  1) KIT, BLO ROBOTIC GYN          , Catalog Number: PBCGRGB28;   2) KIT ,  GYN MAJOR  BARNES JEWIS, Catalog Number: PBVMLP22G;   3) KIT, GYN OPERATIVE LAPAROSCOPY, Catalog Number: PBVM0722D;   4) KIT,MAJOR VAGINAL,PRESBYTERIAN, Catalog Number: PBV2MJMVH;   5) KIT, GYN LAPAROSCOPY          , Catalog Number: PBV2MJMVH;   6) KIT, GYN LAPAROSCOPY          , Catalog Number: PB43LSEJG;   7) GYNE ROBOTIC PACK CMC         , Catalog Number: SMACGGRACE;   8) LH GYN ROBOTICS PK            , Catalog Number: SMAOCGYLHL;   9) DAVINCI PACK WOMENS           , Catalog Number: SMAVPDWTMC;   10) PK GYN ROBOTICS OD            , Catalog Number: SMA4JGRODB;   11) PK LAPAROSCOPY GYN OD         , Catalog Number: SMA4JLGODA",
      "product_quantity": "1398 units",
      "reason_for_recall": "The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.",
      "recall_initiation_date": "20260729",
      "center_classification_date": "20260903",
      "report_date": "20260909",
      "code_info": "1) PBCGRGB28, UDI-DI: 10198956432567(each), 50198956432565(case), Lot Number: GKU1823                       ; 2) PBVMLP22G, UDI-DI: 10198956123854(each), 50198956123852(case), Lot Number: NGKU2052                      ; 3) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0856                      ; 4) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0957                      ; 5) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0856                      ; 6) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0957                      ; 7) PBV2MJMVH, UDI-DI: 10198956285248(each), 50198956285246(case), Lot Number: NGKV3390                      ; 8) PB13GYAJD, UDI-DI: 10198956125193(each), 50198956125191(case), Lot Number: NGKV3390                      ; 9) PB43LSEJG, UDI-DI: 10198956200999(each), 50198956200997(case), Lot Number: NGKW2883                      ; 10) SMACGGRACE, UDI-DI: 10197106820506(each), 50197106820504(case), Lot Number: NGKU0856                      ; 11) SMACGGRACE, UDI-DI: 10197106820506(each), 50197106820504(case), Lot Number: NGKU2052                      ; 12) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW0682                      ; 13) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769                      ; 14) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769                      ; 15) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769                      ; 16) SMAVPDWTMC, UDI-DI: 10197106678053(each), 50197106678051(case), Lot Number: GKU1823                       ; 17) SMAVPDWTMC, UDI-DI: 10197106678053(each), 50197106678051(case), Lot Number: GKU1823                       ; 18) SMA4JGRODB, UDI-DI: 10197106670545(each), 50197106670543(case), Lot Number: NGKU0129                      ; 19) SMA4JGRODB, UDI-DI: 10197106670545(each), 50197106670543(case), Lot Number: NGKU0129                      ; 20) SMA4JLGODA, UDI-DI: 10197106674949(each), 50197106674947(case), Lot Number: NGKU0129                      ; 21) SMA4JLGODA, UDI-DI: 10197106674949(each), 50197106674947(case), Lot Number: NGKU0129",
      "more_code_info": ""
    }
  ]
}