Recall events
/
Event 98060
Event summary
Timeline bucket November 11, 2025
Product types Device
Classifications Class I
Statuses Ongoing
Recalling firm wording AVID Medical, 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
3 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 3
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Z-1000-2026
Recall number Z-1000-2026
Initiated November 11, 2025
Classification Class I
Status Ongoing
Quantity 132 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Devices are not suitable for organ transplant.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1000-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29242]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Devices are not suitable for organ transplant.
Code information Kit Code: LLOG1000-15; UDI: 10809160432679; Lot No: 1632138 & 1648393.
Distribution pattern US Nationwide distribution in the states of FL, GA and Puerto Rico.
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[1648]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Z-1001-2026
Recall number Z-1001-2026
Initiated November 11, 2025
Classification Class I
Status Ongoing
Quantity 52 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Devices are not suitable for organ transplant.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1001-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[29243]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Devices are not suitable for organ transplant.
Code information Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709
Distribution pattern US Nationwide distribution in the states of FL, GA and Puerto Rico.
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[1638]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Z-1002-2026
Recall number Z-1002-2026
Initiated November 11, 2025
Classification Class I
Status Ongoing
Quantity 380 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Devices are not suitable for organ transplant.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1002-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52747]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Devices are not suitable for organ transplant.
Code information Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.
Distribution pattern US Nationwide distribution in the states of FL, GA and Puerto Rico.
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[1469]
FDA event record
· Exact recall-number query on openFDA