DeviceSignal · Recall classified
AVID Medical, Inc.
FDA classified a device recall on 2026-07-31 · Class I · Z-2797-2026
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-2797-2026. The firm initiated it on 2026-04-30. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2797-2026
- 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. SAMMC ANGIOGRAPHY SAMM066-15
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-2797-2026- 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
6db2f1649580cf109e8c201e36551108c95b21a2a0c298ed9878c9fbb86147ba- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)