Windstone Medical AMS Kits Recall
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part
Updated June 17, 2026
Windstone Medical Packaging is recalling multiple AMS Aligned Medical Solutions medical convenience kits that contain Lidocaine HCl injection due to supplier quality issues with the injectable medication.
Is the Windstone Medical Packaging, Inc. recalled? Yes. This product was recalled by FDA on June 17, 2026. Details below.
What is recalled
AMS Aligned Medical Solutions medical convenience kits from Windstone Medical Packaging containing Elevaris Lidocaine HCl injection USP. Affected kits include: Loop Recorder Pack 2-RX (AMS10164), NY Tray-RX (AMS10276A), NYC Tray-RX (AMS10281B), Vein Pack-RX (AMS11398C, AMS15270), Radiology Tray-RX (AMS1217A), Custom Pack-RX (AMS12757B, AMS3081C), Biopsy Tray with Lidocaine-RX (AMS13700), Arthrogram Tray-RX (AMS13755A, AMS15071A, AMS2886A), Myelogram Tray-RX (AMS14805A, AMS15298), Loop Pack-RX (AMS15643), Basic Biopsy Tray-RX (AMS15662A), Pain Pack-RX (AMS17021), Pain Tray-RX (AMS17817), Vasectomy Pack-RX (AMS18226), Basic Procedure Pack-RX (AMS5497), Basic Pack-RX (AMS8130C), Supply Kit-RX (AMS9521A), and Maximal Sterile Barrier Vascular Access Procedure Kit-RX (VK0003MB).
Am I affected
You are affected if you have one of these AMS Aligned Medical Solutions medical convenience kits in your possession. Check the part number printed on your kit's packaging against the list above.
What to do right now
Do not use kits containing Elevaris Lidocaine HCl injection due to supplier quality concerns. Contact Windstone Medical Packaging or the manufacturer for instructions on how to return or dispose of the affected kit.
The hazard
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-2818-2026
- Classification
- Class II
- Recalled
- June 17, 2026
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