Recall events
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Event 89671
Event summary
Timeline bucket February 25, 2022
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Stradis Medical, LLC dba Stradis Healthcare
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
5 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 5
Surgicare Neuro Pack - Neurological Kit
Z-0862-2022
Recall number Z-0862-2022
Initiated February 25, 2022
Classification Class II
Status Ongoing
Quantity 176 units
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
bag may be perforated or torn, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0862-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26832]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
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Inspect official wording and provenance
Reason for recall The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Code information SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545
Distribution pattern US Nationwide distribution in the states of IN, TX, and PA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7250]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
Lum Lam Custom Pack - Anesthesia Kit
Z-0863-2022
Recall number Z-0863-2022
Initiated February 25, 2022
Classification Class II
Status Ongoing
Quantity 21 units
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
bag may be perforated or torn, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0863-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22568]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Code information SKU/Part Number 570-2674; UDI H65257026741 Lot Numbers: 21300478831 and 21314479685
Distribution pattern US Nationwide distribution in the states of IN, TX, and PA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7470]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
Total Knee Pack - Surgical Kit
Z-0864-2022
Recall number Z-0864-2022
Initiated February 25, 2022
Classification Class II
Status Ongoing
Quantity 76 units
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
bag may be perforated or torn, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0864-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45331]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Code information SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Distribution pattern US Nationwide distribution in the states of IN, TX, and PA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7374]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
Anterior Hip Pack - Surgical Kit
Z-0865-2022
Recall number Z-0865-2022
Initiated February 25, 2022
Classification Class II
Status Ongoing
Quantity 100 units
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
bag may be perforated or torn, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0865-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51798]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Code information SKU/Part Number 570-2677; UDI H65257026770 Lot Numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21167474498, 21349479943
Distribution pattern US Nationwide distribution in the states of IN, TX, and PA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7369]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Z-0866-2022
Recall number Z-0866-2022
Initiated February 25, 2022
Classification Class II
Status Ongoing
Quantity 348 units
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
bag may be perforated or torn, which may result in a breach in the sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0866-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45327]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Code information SKU/Part Number 690-260; UDI M7526902600 Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822
Distribution pattern US Nationwide distribution in the states of IN, TX, and PA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[7412]
FDA event record
· Exact recall-number query on openFDA
