Medium risk Electronics & LightingClass II

Windstone Medical Packaging, Inc. 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, Inc. is recalling AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part. Hazard: 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.

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 labeled 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; 10) Arthrogram Tray - RX, Part Number AMS15071A; 11) Vein Pack - RX, Part Number AMS15270; 12) Myelogram Tray - RX, Part Number AMS15298; 13) Loop Pack - RX, Part Number AMS15643; 14) Basic Biopsy Tray - RX, Part Number AMS15662A; 15) Pain Pack -RX, Part Number AMS17021; 16) Pain Tray -RX, Part Number AMS17817; 17) Vasectomy Pack - RX, Part Number AMS18226; 18) Arthrogram Tray- RX, Part Number AMS2886(A; 19) Custom Pack - RX, Part Number AMS3081C; 20) Basic Procedure Pack - RX, Part Number AMS5497; 21) Basic Pack - RX, Part Number AMS8130C; 22) Supply Kit - RX, Part Number AMS9521A; 23) Maximal Sterile Barrier Vascular Access Procedure Kit - RX, Part Number VK0003MB.

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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.

Brands affected

Source
FDA
Category
Electronics & Lighting
Recall ID
fda-Z-2818-2026
Classification
Class II
Recalled
June 17, 2026
Read the official notice

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