{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Sunnyvale",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66918",
      "recalling_firm": "Intuitive Surgical, Inc.",
      "address_1": "1266 Kifer Rd Bldg 100",
      "address_2": "N/A",
      "postal_code": "94086-5304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia.",
      "recall_number": "Z-0520-2014",
      "product_description": "Mega Needle Driver, 8MM assembly of the da Vinci S  IS1200 and da Vinci Si,  IS2000.    Manufactured by Intuitive Surgical, Sunnyvale, CA.    EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.",
      "product_quantity": "15, 236 UPDATED 12/19/13 to 11,235",
      "reason_for_recall": "Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.",
      "recall_initiation_date": "20131115",
      "center_classification_date": "20131216",
      "termination_date": "20140904",
      "report_date": "20131225",
      "code_info": "Part number 400194 on da Vinci IS1200;  Lot numbers:  710191 M10110114  710197 M10110204  710261 M10110217  711061 M10110307  711121 M10110321  711191 M10110425  712071 M10110523  712171 M10110603  801041 M10110621  801151 M10110725  801171 M10110728  801301 M10110810  803171 M10110816  804121 M10110831  805091 M10110909  805271 M10110920  M10090320 S10080609  M10090512 S10080621  M10090709 S10080729  M10090731 S10080812  M10090812 S10080822  M10090824 S10080910  M10090909 S10080918  M10091020 S10081010  M10091110 S10081029  M10091130 S10081106  M10091211 S10081114  M10100114 S10081201  M10100216 S10081215  M10100218 S10090106  M10100428 S10090210  M10100526 S10090303  M10101026 S10090318  M10101103 S10090320  M10101125 S10090410  S10090715  S10110308.  Part number 420194 - used on IS2000:  lot numbers:  510071 M10090629 S10080802  710191 M10090706 S10080818  710261 M10090724 S10080822  711061 M10090727 S10080902  711121 M10090731 S10080910  711151 M10090810 S10080917  711191 M10090825 S10080926  712051 M10090828 S10080930  712131 M10090909 S10081002  712262 M10090916 S10081009  801021 M10091005 S10081014  801151 M10091008 S10081016  801181 M10091012 S10081029  801241 M10091030 S10081106  801301 M10091105 S10081114  802121 M10091123 S10081119  802201 M10091124 S10081202  802251 M10091130 S10081209  803121 M10091204 S10081218  803211 M10091211 S10081229  803261 M10091217 S10090106  804031 M10100105 S10090112  804111 M10100112 S10090114  804221 M10100114 S10090119  805121 M10100120 S10090121  805271 M10100122 S10090227  805301 M10100208 S10090302  M10090316 M10100216 S10090305  M10090324 S10080609 S10090312  M10090423 S10080618 S10090316  M10090505 S10080625 S10090318  M10090512 S10080708 S10090320  M10090528 S10080714 S10090327  M10090609 S10080723 S10090402  M10090624 S10080729 S10090406  M10100218  M10110112  M10110726  M10100224  M10110117  M10110802  M10100311  M10110131  M10110805  M10100318  M10110202  M10110809  M10100407  M10110208  M10110811  M10100412  M10110210  M10110817  M10100415  M10110218  M10110825  M10100429  M10110301  M10110901  M10100519  M10110302  M10110906  M10100526  M10110321  M10110913  M10100527  M10110323  M10110920  M10100531  M10110328  M10110923  M10100603  M10110330  S10110307  M10100615  M10110401  M10100713  M10110412  M10100714  M10110419  M10100722  M10110429  M10100723  M10110503  M10100802  M10110511  M10100809  M10110512  M10101001  M10110523  M10101008  M10110527  M10101019  M10110602  M10101026  M10110609  M10101029  M10110614  M10101104  M10110616  M10101109  M10110620  M10101115  M10110622  M10101117  M10110624  M10101122  M10110627  M10101127  M10110701  M10101206  M10110706  M10101215  M10110707  M10101217  M10110714  M10110107  M10110720"
    }
  ]
}