AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1)… — Class II medical device recall Z-2800-2026
Ongoing recall by Windstone Medical Packaging, Inc., reported 2026-08-05, distributed nationwide. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific l
| Recall number | Z-2800-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2026-06-08 |
| Classified | 2026-07-24 |
| Reported by FDA | 2026-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 919 units |
| Reason classes | sterility |
| Lot numbers | 201002, 205119, 206649, 211870, 215233, 215924, 217552, 218494, 218967, 219166, 222076, 224914, 227000, 228485, 229370, 230336, 231348, 232214, 235207, 235320, 235699, 237597, 238290, 239311, 239795, 241105, 241458, 241802 |
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.
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-2800-2026. 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.