Aligned Medical AMS16835 Fluids Kit RX — Class II medical device recall Z-2307-2026
Ongoing recall by Windstone Medical Packaging, Inc., reported 2026-06-10, distributed nationwide. Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in c
| Recall number | Z-2307-2026 |
|---|---|
| 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 | 2026-04-27 |
| Classified | 2026-06-03 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 875 kits |
| Lot numbers | 233828, 236048, 236359, 236662, 238580, 239934, 239935 |
Product
Aligned Medical AMS16835 Fluids Kit RX
Reason for recall
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
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-2307-2026. 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.