DeviceSignal · Recall classified
AVID Medical, Inc.
FDA classified a device recall on 2026-08-28 · Class II · Z-3046-2026
EventRecall classified
Effective2026-08-28
ClassificationClass II
On 2026-08-28 the FDA classified a device recall from AVID Medical, Inc. as Class II. Product: Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number…. Recall Z-3046-2026. The firm initiated it on 2026-05-19. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3046-2026
- Classification
- Class II
- Classified on
- 2026-08-28
- Initiated on
- 2026-05-19
- Firm
- AVID Medical, Inc.
- Reason
- The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Product
- Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01; 4) SPINE PACK, Model/Item Number (kit) HSLM53-01; 5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01; 6) SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01; 7) CRANI PACK, Model/Item Number (kit) WECR41-01.
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-3046-2026- Snapshot hash
2ad9ab6cbee6c5eb2f0d4298731a8c9755893d917528d78bf00a015fa69a0494- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
35d46504b05418e838fc04aaa88d8e1502ba94c0318fc8c13370f5e74e5ced12- 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)