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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98045

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

Open FDA event record

Event summary

Timeline bucket
November 14, 2025
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

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

Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.

Z-0926-2026
Recall number
Z-0926-2026
Initiated
November 14, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
42 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal

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

Potential for incomplete seal on header bag.

Code information

Catalog Number: VAST018-10. UDI-DI: 10809160452257. Lot Number: 1651776. Expiration Date: 3/12/2027

Distribution pattern

US distribution to GA, IL, NE, MD.

device · product 2 of 5

Halyard, EP LAB PK. Catalog Number: ESJH009-03.

Z-0927-2026
Recall number
Z-0927-2026
Initiated
November 14, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
240 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal

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

Potential for incomplete seal on header bag.

Code information

Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028.

Distribution pattern

US distribution to GA, IL, NE, MD.

device · product 3 of 5

Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.

Z-0928-2026
Recall number
Z-0928-2026
Initiated
November 14, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
300 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal

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

Potential for incomplete seal on header bag.

Code information

Catalog Number: EUHM009-01. UDI-DI: 10809160346839. Lot Number: 1635477. Expiration Date: 5/29/2028.

Distribution pattern

US distribution to GA, IL, NE, MD.

device · product 4 of 5

Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.

Z-0929-2026
Recall number
Z-0929-2026
Initiated
November 14, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
90 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal

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

Potential for incomplete seal on header bag.

Code information

Catalog Number: JEMJ10-01. UDI-DI: 10809160443217. Lot Number: 1635770. Expiration Date: 7/26/2027.

Distribution pattern

US distribution to GA, IL, NE, MD.

device · product 5 of 5

Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.

Z-0930-2026
Recall number
Z-0930-2026
Initiated
November 14, 2025
Classification
Class II
Status
Ongoing
Recalling firm
AVID Medical, Inc.
Quantity
56 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal

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

Potential for incomplete seal on header bag.

Code information

Catalog Number: EURO016-09. UDI-DI: 10809160461198. Lot Number: 1655501 Expiration Date: 3/31/2027.

Distribution pattern

US distribution to GA, IL, NE, MD.