Windstone Medical Packaging, Inc.: Angiography/angioplasty Kit
Recall Summary Windstone Medical Packaging is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS Angio Pack convenience kits (Part Number AMS9461) used in angiography and angioplasty procedures because they contain Elevaris Lidocaine HCl injection that was recalled due to supplier quality issues. The affected kits were distributed nationwide across multiple states. Healthcare facilities and providers who received these kits should check their inventory against the specific lot numbers identified in the recall.
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
- 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/cb7bb9e0-e17e-4c89-895d-5ed1d468ccc5