Halyard medical convenience kits labeled as: 1) A-P PACK — Class II medical device recall Z-3046-2026
Ongoing recall by AVID Medical, Inc., reported 2026-09-09, distributed nationwide. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific l
| Recall number | Z-3046-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVID Medical, Inc., Toano, VA, United States |
| Recall initiated | 2026-05-19 |
| Classified | 2026-08-28 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 816 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10809160473146, 10809160473573, 10809160473979, 10809160476888, 10809160479537, 10809160479797, 10809160485392 |
| Lot numbers | 341654, 341835, 342005, 343206, 343208, 343412, 343413, 343414, 343416, 343713, 343714, 343715, 343716, 343717, 343718, 343719, 343723, 343746, 343747, 343771, 344071, 344464, 345289, 345694, 346967, 346982, 347906, 374128, 374129, 374296 |
| Model numbers | 10809160473146, 10809160473573, 10809160473979, 10809160476888, 10809160479537, 10809160479797, 10809160485392, 341654, 341835, 342005, 343206, 343208, 343412, 343413, 343414, 343416, 343713, 343714, 343715, 343716, 343717, 343718, 343719, 343723, 343746 and 19 more |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3046-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.