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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85474

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 07, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stryker Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-1925-2020
Recall number
Z-1925-2020
Initiated
January 07, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Corporation
Quantity
26,298 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed pouch

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile drapes packaged in an unsealed pouch.

Code information

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.

Distribution pattern

US - Nationwide & Puerto Rico OUS - 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, Philippines, and New Zealand.

device · product 2 of 2

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

Z-1926-2020
Recall number
Z-1926-2020
Initiated
January 07, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Corporation
Quantity
21,078 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
unsealed pouch

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile drapes packaged in an unsealed pouch.

Code information

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

Distribution pattern

US - Nationwide & Puerto Rico OUS - 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, Philippines, and New Zealand.