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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98060

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

Open FDA event record

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
Recalling firm
AVID Medical, Inc.
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

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.

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
Recalling firm
AVID Medical, Inc.
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

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.

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
Recalling firm
AVID Medical, Inc.
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

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.