{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Trumbull",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76980",
      "recalling_firm": "CooperSurgical, Inc.",
      "address_1": "95 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "06611-1350",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distributed - US Nationwide in the states of: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN, KS,KY,LA,MA,MD, ME, MI, MN, MO, MS, MT, NC,ND,NE, N H, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and countries of: AUSTRALI A,BAHAMAS,BRAZIL,CANADA, COLOMBIA, COSTA RICA, DENMARK, ENGLAND, GREECE, GUAM, ISRAEL, LITHUANIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PANAMA, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, and SWEDEN",
      "recall_number": "Z-2054-2017",
      "product_description": "CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit.    Product Usage:  The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).",
      "product_quantity": "7126 units (total for all products)",
      "reason_for_recall": "The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.",
      "recall_initiation_date": "20170410",
      "center_classification_date": "20170508",
      "termination_date": "20171101",
      "report_date": "20170517",
      "code_info": "142947  142948  142949  146348  153078  153079  157415  160844  166923  166924  166925  178346  178347  178348  182458  185831  185832  185834  185835  185836  211779  219502  139577  141310  142937  146344  150141  153064  153065  157402  160467  162612  166911  178317  183618  183619  185809  185810  185812  185814  211776  212978  218621  218622  135402  141313  142941  144528  153069  153070  157406  157407  160839  166915  166916  166917  178320  178321  178322  178323  185818  185822  185823  185824  201919  212980  215758  121937  142944  144530  153074  157411  160842  178332  178333  178334  178335  182453  185826  185827  218669  139581  139582  139583  142946  144532  146347  153076  153077  157414  178343  178344  182455  182456  182457  200176  212983  215760"
    }
  ]
}