RecallRadar

FDA Device recall Z-2814-2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A

On 2026-08-05 the FDA classified a Class II recall of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A 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

AgencyFDA Device
Recall numberZ-2814-2026
ClassificationClass II
Statusongoing
Initiated2026-06-17
Published2026-08-05
Last updated2026-09-13 11:58 UTC
CompanyWindstone Medical Packaging
DistributionUS

Product

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray- RX, Part Number AMS2009; 3) Nerve Block Tray - RX, Part Number AMS3224.

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 AMS13975A, UDI/DI B098AMS13975A0, Lot Numbers: 230376, 241103; Part Number AMS2009, UDI/DI B098AMS20090,…Part Number AMS13975A, UDI/DI B098AMS13975A0, Lot Numbers: 230376, 241103; Part Number AMS2009, UDI/DI B098AMS20090, Lot Numbers: 216938, 240939; Part Number AMS3224, UDI/DI B098AMS32240, Lot Numbers: 231314.

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-2814-2026%22

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