- Recalling firm
- Windstone Medical Packaging, Inc.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 950 kits
- Distribution pattern
- 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.
- Firm location
- Billings, MT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2814-2026
- Recall initiated
- June 17, 2026
- FDA classification date
- July 27, 2026
- FDA report date
- August 5, 2026
- FDA event ID
- 99347
- Last updated on HTM Vibe
- August 11, 2026