Windstone Medical Packaging, Inc.: Spinal Epidural Anesthesia Kit
Recall Summary Windstone Medical Packaging is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS Spinal Kits (Part Number AMS13683A) that contain Elevaris Lidocaine HCl injection due to supplier quality issues with the lidocaine component. The recall affects medical facilities nationwide that received these kits. This is a Class II recall, meaning the product could cause serious adverse health effects or temporary loss of normal function.
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-17
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f7b60e1d-8d6d-4b50-a0af-07eb7777be7a