AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1)… — Class II medical device recall Z-2802-2026
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-2802-2026 |
|---|---|
| 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 | 7,306 units |
| Reason classes | sterility |
| Lot numbers | 176784, 179837, 181956, 184890, 191784, 194017, 196708, 197543, 199137, 201956, 210134, 211888, 213914, 215434, 215450, 215711, 216076, 216357, 217352, 218234, 218443, 218696, 219827, 219872, 221799, 222621, 222999, 223361, 223766, 224253, 224568, 224717, 225039, 225332, 226168, 226497, 226627, 226657, 227324, 227667 and 57 more |
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278; 6) Spine Pack, Pack Number AMS16499; 7) Spine Pack, Pack Number AMS16709; 8) Lumbar Spine Pack, Pack Number AMS17336; 9) Laminectomy Pack, Pack Number AMS17945; 10) Anterior Cervical Pack, Pack Number AMS17946; 11) Spine Pack, Pack Number AMS3150F; 12) Spine Pack, Pack Number AMS3150G; 13) Spine Pack, Pack Number AMS5451D; 14) ENT Pack, Pack Number AMS9771.
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-2802-2026. 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.