{
  "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": [
    {
      "status": "Terminated",
      "city": "Tempe",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81430",
      "recalling_firm": "Stryker Sustainability Solutions",
      "address_1": "1810 W Drake Dr",
      "address_2": "N/A",
      "postal_code": "85283-4327",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US nationwide distribution in the states of OK, GA, NJ, TX, IA, CO, TX, CA, LA, PA, VA, MD, WA, and IL.    OUS:  None.",
      "recall_number": "Z-0498-2019",
      "product_description": "Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.  Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.",
      "product_quantity": "4848",
      "reason_for_recall": "Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor.",
      "recall_initiation_date": "20180619",
      "center_classification_date": "20181127",
      "termination_date": "20241115",
      "report_date": "20181205",
      "code_info": "Lot     Number  3727435   3732833   3732851   3752003   3762495   3762972   3765649   3783776   3775681   3779516   3782202   3784430   3786146   3794419   3803918   3810037   3811778   3809891   3821740   3829338   3833206   3834196   3853141   3854774   3861804   3863303   3870240   3873578   3881364   3886277   3866398   3890070   3890089   3880942   3894678   3896022   4113667   4118604   4133825   3849330   4138769   4147801   4154685   4158429   4170275   4173170   4187693   4198853   4202332   4235633   4245630   4274018   4282444   4386368   4515596   4459232   4458288   4466644   4467337   4466103   4473956   4474932   4476349   4477829   4479578   4512285   4513266   4530457   4533116   4548738   4551779   4557026   4566912   4572487   4571871   4574911   4576443   4576086   4577407   4581177   4580431   4583936   4589373   4593587   4603588   4597997   4602957   4598476   4607573   4608496   4608514   4615536   4609747   4610175   4610894   4611167   4611179   4612670   4613359   4614603   4618135   4615246   4616746   4659568   4659478   4660191   4671055   4662392   4663276   4664364   4668273   4669208   4672293   4670712   4667846   4668260   4668287   4670139   4674512   4674857   4074165   4672065   4680853   4681245   4683268   4686942   4688031   4688326   4688887   4688894   4690786   4695707   4704437   4698746"
    }
  ]
}