Exact FDA event identifier

Event 98298

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: January 02, 2026
Product types: Device
Classifications: Class II
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

1 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 1

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

Z-1338-2026

Recall number: Z-1338-2026
Initiated: January 02, 2026
Classification: Class II
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 1,500 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

bag seal issue which may compromise

Sterility assurance reason.sterility_assurance · v1.0.0

bag seal issue which may compromise sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tyvek bag seal issue which may compromise sterility of the kit.

Code information

Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028

Distribution pattern

US Nationwide distribution in the states of New Jersey.