FDAFDA · Food and drugs·Recall number Z-2812-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Published August 5, 2026 · Recall initiated: June 17, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
- Lot
- UDI/DI B098AMS13683A0, Lot Number 230451
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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