Recall events
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Event 93807
Event summary
Timeline bucket December 22, 2023
Product types Device
Classifications Class I
Statuses Ongoing
Recalling firm wording Windstone Medical Packaging, Inc.
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
4 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 4
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Z-1079-2024
Recall number Z-1079-2024
Initiated December 22, 2023
Classification Class I
Status Ongoing
Quantity 1,528 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Sterility assurance for saline included in surgical kits cannot be guaranteed.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1079-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28561]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Sterility assurance for saline included in surgical kits cannot be guaranteed.
Code information DI: B098AMS108330/Lot #s: 173719 176590 174338 175529 176217 178271 178489 180907 183355 183674 184398 185064 188137 189007 189640 189641 189642 191067 192551 196380 197727 198046 198373 181439 194252 199297
Distribution pattern US: FL, IL, CA OUS: None
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[36259]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 4
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Z-1080-2024
Recall number Z-1080-2024
Initiated December 22, 2023
Classification Class I
Status Ongoing
Quantity 128 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Sterility assurance for saline included in surgical kits cannot be guaranteed.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1080-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34877]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Sterility assurance for saline included in surgical kits cannot be guaranteed.
Code information UDI: B098AMS12947A0/Lot #s: 192436, 192774, 196582
Distribution pattern US: FL, IL, CA OUS: None
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[36964]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 4
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Z-1081-2024
Recall number Z-1081-2024
Initiated December 22, 2023
Classification Class I
Status Ongoing
Quantity 80 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Sterility assurance for saline included in surgical kits cannot be guaranteed.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1081-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9769]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Sterility assurance for saline included in surgical kits cannot be guaranteed.
Code information UDI: B098AMS129470/ Lot #s: 192389 and 194805
Distribution pattern US: FL, IL, CA OUS: None
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[36871]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 4
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Z-1082-2024
Recall number Z-1082-2024
Initiated December 22, 2023
Classification Class I
Status Ongoing
Quantity 475 kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Sterility assurance for saline included in surgical kits cannot be guaranteed.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1082-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9767]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Sterility assurance for saline included in surgical kits cannot be guaranteed.
Code information UDI: B098AMS130430/Lot #s: 178114 187325 191102 195504 196502 197864
Distribution pattern US: FL, IL, CA OUS: None
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[37036]
FDA event record
· Exact recall-number query on openFDA
