Medical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
Windstone Medical Packaging is recalling 60 AMS Angio Pack-RX convenience kits (lots 230658, 231173) because the included Elevaris Lidocaine HCl injection was recalled by its manufacturer due to supplier quality issues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this recall as Class II, and the source text does not report any hospitalizations, injuries, or deaths. Under the rubric, FDA Class II without hospitalization reports corresponds to Moderate (score 2).
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 60 AMS Aligned Medical Solutions medical convenience kits labeled as Angio Pack - RX, Part Number AMS9461. The affected kits contain Elevaris Lidocaine HCl injection USP, which Elevaris Medical Devices Inc. recalled due to supplier quality issues. The recall covers UDI/DI B098AMS94610 and Lot Numbers 230658 and 231173.
These kits were distributed nationwide in the United States, including AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, and WA. The U.S. Food and Drug Administration lists this recall as a Class II recall.
Consumers who have an affected kit should check the lot number against the recalled lots and contact Windstone Medical Packaging, Inc. or their healthcare provider for further instructions. The recall is limited to the specific lots listed in the notice.
The recalled product
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- supplier-quality-issue
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI B098AMS94610
- Lot Numbers: 230658
- 231173.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking After Sterilization
FDA (Devices) · 2026-08-05
- ModerateAMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05