DeviceSignal · Recall classified

AVID Medical, Inc.

FDA classified a device recall on 2026-07-31 · Class I · Z-2796-2026

EventRecall classified
Effective2026-07-31
ClassificationClass I

On 2026-07-31 the FDA classified a device recall from AVID Medical, Inc. as Class I. Product: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…. Recall Z-2796-2026. The firm initiated it on 2026-04-30. This reports the classification FDA published on that date.

Reported facts

Recall number
Z-2796-2026
Classification
Class I
Classified on
2026-07-31
Initiated on
2026-04-30
Firm
AVID Medical, Inc.
Reason
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Product
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05

Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.

Provenance

Source
fda_device_enforcement
Source record
Z-2796-2026
Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72
Source URL
https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
Observed
2026-09-08T16:22:09.483Z
Transform
fda_device_enforcement_to_recall v1
Event rule
fda_device_recall_classified v1
Event key
ff016a64e0a5d5daf5d7c9bc8163efef92f2ebce8c722e74cd6048afb885018b
Signal type
device_recall.classified

Source terms that apply

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Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)