FDA Device recall Z-2815-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
- FDA Device
- Class II
- ongoing
- Published 2026-08-05
On 2026-08-05 the FDA classified a Class II recall of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461 by Windstone Medical Packaging, citing windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Li….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2815-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-17 |
| Published | 2026-08-05 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Windstone Medical Packaging |
| Distribution | US |
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
Reason
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Identifiers
| code_info | UDI/DI B098AMS94610, Lot Numbers: 230658, 231173. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2815-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.