AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1)… — Class II medical device recall Z-2799-2026
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-2799-2026 |
|---|---|
| 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 | 465 units |
| Reason classes | sterility |
| Lot numbers | 172113, 173334, 176227, 176639, 177152, 179354, 180388, 182683, 184684, 186205, 186406, 187036, 188521, 189734, 190090, 190810, 191564, 192202, 192735, 192848, 194365, 195253, 196504, 197149, 197188, 197866, 199463, 199488, 199844, 201971, 202475, 202549, 202783, 202880, 204081, 204268, 205388, 205844, 206750, 206922 and 120 more |
| Model numbers | AMS10411B, AMS10411C, AMS11963A, AMS12636C, AMS12731, AMS13150, AMS13150A, AMS13150B, AMS14496A, AMS14496B, AMS14496C, AMS14736, AMS16417, AMS16586, AMS16586A, AMS7619A, AMS7819A |
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6) Septoplasty Pack, Part Number AMS13150; 7) Septoplasty Pack, Part Number AMS13150A; 8) Septoplasty Pack, Part Number AMS13150B; 9) Rhinoplasty Pack, Part Number AMS14496A; 10) Rhinoplasty Pack, Part Number AMS14496B; 11) Rhinoplasty Pack, Part Number AMS14496C; 12) Laryngoscopy Pack, Part Number AMS14736; 13) Nasal and Sinus Pack, Part Number AMS16417; 14) Major Pack, Part Number AMS16586; 15) Major Pack, Part Number AMS16586A; 16) Nasal and Sinus Pack, Part Number AMS7619A; 17) Sinus Pack, Part Number AMS7819A.
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-2799-2026. 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.