{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "181041", "product_res_number": "Z-1925-2020", "event_date_initiated": "2020-01-07", "event_date_created": "2020-05-07", "recall_status": "Open, Classified", "res_event_number": "85474", "product_code": "MMP", "k_numbers": [ "K162885" ], "product_description": "Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US.\nDrape/ UDI: HH2000/10858701006329; \nHH9006/ 10858701006282", "code_info": "Impacted Lot Numbers for HH2000 - 1703011, 1703021, 1703031, 1703041, 1703051, 1703061, 1703071, 1703081, 1703091, 1703101, 1703111, 1703121, 1703131, 1703141, 1703151, 1703161, 1703171, 1703181, 1703191, 1703201, 1703211, 1703221, 1703231, 1703241, 1703251, 1703261, 1703271, 1703281, 1703291, 1703301, 1703311, 1704011, 1704021, 1704031, 1704041, 1704051, 1704061, 1704071, 1704081, 1704091, 1704101, 1704111, 1704121, 1704131, 1704141, 1704151, 1704161, 1704171, 1704181, 1704191, 1704201, 1704211, 1704221, 1704231, 1704241, 1704251, 1704261, 1704271, 1704281, 1704291, 1704301, 1705011, 1705021, 1705031, 1705041, 1705051, 1705061, 1705071, 1705081, 1705091, 1705101, 1705111, 1705121, 1705131, 1705141, 1705151, 1705161, 1705171, 1705181, 1705191, 1705201, 1705211, 1705221, 1705231, 1705241, 1705251, 1705261, 1705271, 1705281, 1705291, 1705301, 1705311, 1706011, 1706021, 1706031, 1706041, 1706051, 1706061, 1706071, 1706081, 1706091, 1706101, 1706111, 1706121, 1706131, 1706141, 1706151, 1706161, 1706171, 1706181, 1706191, 1706201, 1706211, 1706221, 1706231, 1706241, 1706251, 1706261, 1706271, 1706281, 1706291, 1706301, 1707011, 1707021, 1707031, 1707041, 1707051, 1707061, 1707071, 1707081, 1707091, 1707101, 1707111, 1707121, 1707131, 1707141, 1707151, 1707161, 1707171, 1707181, 1707191, 1707201, 1707211, 1707221, 1708221, 1709221, 1710191, 1710201, 1710211, 1710221, 1711191, 1711201, 1711211, 1711221, 1711231, 1712021, 1712041, 1712051, 1712061, 1712071, 1712081, 1712091, 1712111, 1712121, 1712131, 1712141, 1712151, 1712161, 1712181, 1712271, 1712281, 1712291, 1712301, 1801031, 1801111, 1805251, 1805261, 1805271, 1805281, 1805291, 1805301, 1805311, 1806011, 1806021, 1806041, 1806051, 1806061, 1806071, 1806091, 1806111, 1806201, 1806211, 1807031, 1807061, 1807071, 1807091, 1807251, 1807261, 1807271, 1808171, 1808181, 1808201, 1808221, 1808231, 1808241, 1808301, 1808311, 1809011, 1809021, 1809031, 1810041, 1810051, 1810061, 1812051, 1812151, 1902231, 1902241, 1902251, 1902261, 1902271, 1902281, 1903011, 1903021, 1903031, 1903181, 1903191, 1903201, 1903211, 1903221, 1903271, 1903281, 1904231, 1904241, 1904251, 1904291, 1905141, 1905151, 1905161, 1905171, 1905211, 1905221, 1905231, 1905241, 1905251, 1906241, 1906251, 1906271, 1906281, 1906291, 1907011, 1907221, 1907231, 1907241, 1907251, 1907261, 1907271, 1907311, 1908011, 1908021, 1908031, 1908051, 1908061, 1908071, 1908081, 1908091, 1908151  HH9006 Spy-Phi Pack Impacted Lot Numbers - 1701x, 1702x, 1703x, 1704x, 1705x, 1706x, 1707x, 1708x, 1709x, 1710x, 1711x, 1712x, 1801x, 1802x, 1803x, 1804x, 1805x, 1806x, 1807x, 1808x, 1809x, 1810x, 1811x, 1812x, 1901x, 1902x, 1903x, 1904x, 1905x, 1906x, 1907x, 1908x, 1909x, 19103. Where x is any alpha numeric character.", "firm_fei_number": "2936485", "recalling_firm": "Stryker Corporation", "address_1": "5900 Optical Ct", "city": "San Jose", "state": "CA", "postal_code": "95138-1400", "additional_info_contact": "Mr. Brent Ladd\n408-754-2000", "reason_for_recall": "Sterile drapes packaged in an unsealed pouch.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to the affected customers on 01/07/2020 informing them of the product field action prompting them to send any unused affected units back to the manufacturer.", "product_quantity": "26,298 units", "distribution_pattern": "US - Nationwide & Puerto Rico\nOUS - Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, South Korea, Australia, Chile, China, Germany, France, United Kingdom, Hong Kong, India, Italy, Singapore, Thailand, Romania, Belgium, Sweden, Switzerland, Austria, Malaysia, Finland, Denmark, Israel, Qatar, Kazakhstan, Turkey, Czech Republic, Greece, Russia, Poland, Ireland,\nPhilippines, and New Zealand.", "openfda": { "k_number": [ "K091178", "K032065", "K944198", "K023540", "K931417", "K040794", "K962288", "K961699", "K043234", "K930552", "K820692", "K041501", "K952241", "K014239", "K970885" ], "registration_number": [ "1722021", "3007082897", "1054241", "3015499242", "1643817", "1043214", "1423537", "1061124", "1060680", "3004122598", "3009544661", "3014325891", "3008850249", "3012494290", "2936485", "1417592", "3002696493", "1644312", "1423625", "3018094310", "3010014065", "1319639", "3012477813", "3004111573", "2320762", "2183744", "1055236", "3033043422", "9614209", "2183301", "1018470", "3013429557", "9680357", "3011494917", "1625425", "3042129477", "9616088", "3015173212", "3007007790", "3010453313", "9680506", "3013046958", "3003495693", "3010305275", "3004046477", "3006973666", "3007539307", "8043980", "3004362278", "1717344", "1836161", "3008654268", "3016761372", "3004496839", "3006581049", "3010202439" ], "fei_number": [ "3007082897", "3003040625", "3015499242", "1643817", "1043214", "3002914049", "1000112968", "3002750084", "1000208624", "3002806725", "3004122598", "3009544661", "3014325891", "3008850249", "1000112877", "3012494290", "2936485", "1417592", "3002696493", "1000117748", "3018094310", "3010014065", "1000117344", "3004829691", "3012477813", "3004111573", "2183744", "3033043422", "2183301", "1018470", "3013429557", "1000138054", "3011494917", "1625425", "3002939620", "3007475226", "3042129477", "3015173212", "3007007790", "3010453313", "3013046958", "3003495693", "3004046477", "3010305275", "3006973666", "3007539307", "3001236905", "3004362278", "1717344", "3008654268", "3016761372", "3004496839", "3006581049", "1000512168", "3000210101", "3002902735" ], "device_name": "Cover, Barrier, Protective", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }