MEDICAL DEVICE RECALLMODERATE

AMS Spinal Kit

AMS SPINAL KIT recalled due to supplier quality issues with included Lidocaine HCl injection.

What to do

Check your inventory for AMS convenience kits labeled SPINAL KIT, Part Number AMS13683A. Stop using the kits and contact Windstone Medical Packaging for instructions on returning the affected product and obtaining a replacement.

Recalled

2026-06-17

Listed

2026-07-27

Updated

2026-09-03

Recall No.

Z-2812-2026

Agency

FDA

Firm

Windstone Medical Packaging, Inc.

Recall ID

99347

Status

ONGOING

Why it was recalled

Windstone Medical Packaging is recalling Aligned Medical Solutions (AMS) convenience kits labeled as SPINAL KIT, Part Number AMS13683A, because they contain Elevaris Lidocaine HCl injection USP that was recalled by Elevaris Medical Devices Inc. due to supplier quality issues.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled

Product	Lot code	Recall #	UDI-DI
as	230376, 241103, 216938, 240939, 231314	Z-2814-2026	–
as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B; 4) Vein Pack - RX, Part Number AMS11398C; 5) Radiology Tray-RX, Part Number AMS1217A; 6) Custom Pack - RX, Part Number AMS12757B; 7) Biopsy Tray w/Lidocaine - RX, Part Number AMS13700; 8) Arthrogram Tray - RX, Part Number AMS13755A; 9) Myelogram Tray - RX, Part Number AMS14805A;	–	Z-2818-2026	00813623010666
as: Port Tray - RX, Part Number 008786-19	230451	Z-2819-2026	–
as: Heart Cath Tray - RX, Part Number DDS1159B	214412	Z-2816-2026	–
as: Block Tray - RX, Part Number AMS12414	230411	Z-2817-2026	–
as: SPINAL KIT, Part Number AMS13683A	230451	Z-2812-2026	–
as	231043, 229846, 216803, 240843, 230645, 231078, 230958, 231238, 241232, 217313, 230948	Z-2813-2026	–
as: Angio Pack - RX, Part Number AMS9461	230658, 231173	Z-2815-2026	–
as	230816, 230588, 230589, 230590, 230893, 241165, 215784, 231259, 241171, 230680, 217313, 240360, 217431, 230376, 241103, 217790, 230689, 230667, 216398, 241219, 241307, 230737, 231023, 241136, 241031, 230745, 230716, 230851, 217634, 217635, 231235, 231236, 240963, 217055, 217429	–	B098AMS101640, B098AMS10276A0, B098AMS10281B0, B098AMS11398C0, B098AMS1217A0, B098AMS12757B0, B098AMS137000, B098AMS13755A0, B098AMS14805A0, B098AMS15071A0, B098AMS152700, B098AMS152980, B098AMS156430, B098AMS15662A0, B098AMS170210, B098AMS178170, B098AMS182260, B098AMS2886, B098AMS3081C0, B098AMS54970, B098AMS8130C0, B098AMS9521A0, 00813623010666

Where it was sold

Distributed nationwide.

Timeline

2026-06-17Firm initiated recall
2026-07-27Publicly announced
2026-07-28Listed on Recall Canary
2026-09-03Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification