DeviceSignal · Recall classified
AVID Medical, Inc.
FDA classified a device recall on 2026-08-14 · Class II · Z-2964-2026
EventRecall classified
Effective2026-08-14
ClassificationClass II
On 2026-08-14 the FDA classified a device recall from AVID Medical, Inc. as Class II. Product: Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization…. Recall Z-2964-2026. The firm initiated it on 2026-07-10. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2964-2026
- Classification
- Class II
- Classified on
- 2026-08-14
- Initiated on
- 2026-07-10
- Firm
- AVID Medical, Inc.
- Reason
- The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
- Product
- Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
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-2964-2026- 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
72f6f05a7ba7915572ea6509b84ff64ed6e803f089aeb807243207f0c2cf5c3a- 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)