{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "North Haven",
      "address_1": "60 Middletown Ave",
      "reason_for_recall": "The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin. Medtronic has received, worldwide, a total of ten reports of mesh failure following use of the product in the last five years. Patients who have received a Parietex\" composite parastomal mesh for the treatment of a parastomal hernia should continue to receive ongoing monitoring by their healthcare providers for the recurrence of a parastomal hernia.",
      "address_2": "",
      "product_quantity": "7333",
      "code_info": "Lots  PNI0064  PNI0065  PNI0402  PNJ0496  PNJ0989  PNJ0990  PNK0641  PNL0037  PNL0039  PNL0631  POA0469X  POA0963X  POB0030X  POB0797X  POC0036X  POC0726X  POD0033X  POD0036X  POD1016X  POE0149X  POE0262X  POE0727X  POF0295X  POF0298X  POG0047X  POH0069X  POH0070X  POI0260X  POI0261X  POI0489X  POJ0418X  POJ0880X  POK0364X  POK0366X  POK0789X  POK0790X  POL0082X  PPA0226X  PPA0227X  PPA0508X  PPA0509X  PPB0779X  PPB0780X  PPC0578X  PPD0409X  PPD0410X  PPE0215X  PPE0509X  PPF0179X  PPF0181X  PPF0836X  PPG0035X  PPG0723X  PPH0355X  PPI0630X  PPI0631X  PPI1144X  PPI1145X  PPJ0234X  PPJ0235X  PPJ0698X  PPK0523X  PPK0524X  PPL0082X  PPL0353X  PQA0483X  PQC0100X  PQC0102X  PQD0395X  PQD0397X  PQE0187X  PQE0802X  PQG0391X  PQG1150X  PQG1152X  PQH0608X  PQH0610X  PQI1246X  PQI1248X  PQJ0971X  PQJ0973X  PQK0314X  PQK0316X  PQL0150X  PQL0479X  PQL0481X  PRA1193X  PRA1195X  PRA1655X  PRA1657X  PRA2444X  PRA2446X  PRB1650X  PRB1652X  PRB2015X  PRB2017X  PRC0392X  PRC0394X  PRC1062X  PRC1064X  PRD0248X  PRD0250X  PRD0547X  PRD0549X  PRD1170X  PRD1172X  PRE0479X  PRE0481X  PRE1319X  PRF0408X  PRF0410X  PRG0382X  PRG1020X  PRG1022X  PRH0323X  PRH0325X  PRI0530X  PRI0531X  PRI1166X  PRI1168X  PRI1409X  PRI1411X  PRJ0480X  PRJ0482X  PRK0758X  PRK0760X  PRK1140X  PRK1142X  PRL0129X  PRL0131X  PRL0528X  PRL0530X  PSA0833X  PSA0835X  PSA1207X  PSA1209X  PSB0936X  PSB0938X  PSC0186X  PSC0188X  PSD0420X  PSD0422X  PSE0906X  PSE0908X  PSF0217X  PSF0219X  PSG0778X  PSG0780X  RQA1121X  PRG0380X",
      "center_classification_date": "20181114",
      "distribution_pattern": "Worldwide distribution--US Nationwide",
      "state": "CT",
      "product_description": "Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20)    Product Usage:  The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is completely covered with the hydrophilic film. On the opposite side, only the two-dimensional central band is coated with the absorbable hydrophilic film. The film extends 5 mm over the external edge of the reinforcement. The Parietex composite parastomal mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.",
      "report_date": "20181121",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Covidien LLC",
      "recall_number": "Z-0461-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81417",
      "termination_date": "20200507",
      "more_code_info": "",
      "recall_initiation_date": "20181005",
      "postal_code": "06473-3908",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}