Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the… — Class II medical device recall Z-0028-2025
Ongoing recall by Windstone Medical Packaging, Inc., reported 2024-10-16, distributed nationwide. Due to convenience kits containing a kit component that is under a recall action for improper use.
| Recall number | Z-0028-2025 |
|---|---|
| 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 | 2024-08-16 |
| Classified | 2024-10-08 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 894 kits |
| Lot numbers | 158265, 164363, 167626, 169363, 173648, 178341, 186343, 192237, 193165, 194502, 196521, 201447, 202990, 205757, 208807, 210226, 211594, 212449 |
| Model numbers | AMS9977 |
Product
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Reason for recall
Due to convenience kits containing a kit component that is under a recall action for improper use.
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-0028-2025. 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.