AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1)… — Class II medical device recall Z-2801-2026
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-2801-2026 |
|---|---|
| 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 | 927 units |
| Reason classes | sterility |
| Lot numbers | 212195, 216097, 216766, 217573, 217757, 217806, 219221, 220779, 220948, 222013, 222070, 222520, 222686, 223506, 223714, 224418, 224581, 225092, 225587, 225839, 226568, 226652, 227439, 227717, 227813, 228598, 230393, 230569, 231091, 233313, 233855, 234027, 234138, 234503, 234756, 235331, 235909, 235956, 236416, 236502 and 11 more |
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine Pack, Pack Number AMS16313; 5) Lami Kukkar Pack, Pack Number AMS17958; 6) Neuro Pack, Pack Number AMS6452B; 7) Neuro Lami Pack, Pack Number AMS9427C.
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-2801-2026. 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.