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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Stryker Corporation: Sterile drapes packaged in an unsealed pouch.

Agency Publication Date: May 7, 2020
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Affected Products

Product: Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282

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.

Lot Numbers:
Numbers
Numbers
Product: Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326

Impacted Lot Numbers - 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

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85474
Status: Active
Manufacturer: Stryker Corporation
Manufactured In: United States
Units Affected: 2 products (26,298 units; 21,078 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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