AMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
Windstone Medical Packaging is recalling specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 recall is classified as FDA Class II, which indicates a remote possibility of adverse health consequences.
Plain-English summary
Windstone Medical Packaging, Inc. has issued a recall for specific AMS Aligned Medical Solutions medical convenience kits. These kits contain Elevaris Lidocaine HCl injection USP.
The recall was initiated due to supplier quality issues identified by Elevaris Medical Devices Inc. The affected products include various trays such as Single Shot Epi Trays, Epidural Trays, and Nerve Block Trays.
Distribution of the 580 affected kits was nationwide across several US 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 recalled product
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part…
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- Affected units
- 580
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 (20)
- Part Number AMS1095(E
- UDI/DI B098AMS1095(E0
- Lot Numbers: 231043
- Part Number AMS11296A
- UDI/DI B098AMS11296A0
- Lot Numbers: 229846
- Part Number AMS11314A
- UDI/DI B098AMS11314A0
- Lot Numbers: 216803
- 240843
- Part Number AMS11910A
- UDI/DI B098AMS11910A0
- Lot Numbers: 230645
- 231078
- Part Number AMS12171
- UDI/DI B098AMS121710
- Lot Numbers: 230958
- 231238
- 241232
- Part Number AMS12219A
Distribution
Part of a larger recall action
This product is one of 8 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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See all →- ModerateAMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
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