FDA Device recall Z-2813-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E
- 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: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E 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-2813-2026 |
| 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: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part Number AMS11910A; 5) Nerve Block Tray - RX, Part Number AMS12171; 6) Single Shot Epidural Tray - RX, Part Number AMS12219A; 7) Universal Block Tray - RX, Part Number AMS12381B.
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 | Part Number AMS1095(E, UDI/DI B098AMS1095(E0; Lot Numbers: 231043; Part Number AMS11296A, UDI/DI B098AMS11296A0; Lot…Part Number AMS1095(E, UDI/DI B098AMS1095(E0; Lot Numbers: 231043; Part Number AMS11296A, UDI/DI B098AMS11296A0; Lot Numbers: 229846; Part Number AMS11314A, UDI/DI B098AMS11314A0; Lot Numbers: 216803, 240843; Part Number AMS11910A, UDI/DI B098AMS11910A0; Lot Numbers: 230645, 231078; Part Number AMS12171, UDI/DI B098AMS121710; Lot Numbers: 230958, 231238, 241232; Part Number AMS12219A, UDI/DI B098AMS12219A0; Lot Numbers: 217313; Part Number AMS12381B, UDI/DI B098AMS12381B0; Lot Numbers: 230948. |
|---|
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-2813-2026%22
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