Quick Facts at a Glance
- Recall Date
- June 17, 2026
- Hazard Level
- HIGH
- Brand
- Windstone Medical Packaging
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Windstone Medical Packaging
- Model numbers
- 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 +12 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 17, 2026
Reported by FDA DEVICE
August 5, 2026
RecallRadar source check
August 12, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Windstone Medical Packaging, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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Full Description
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 Number AMS11910A; 5) Nerve Block Tray - RX, Part Number AMS12171; 6) Single Shot Epidural Tray - RX, Part Number AMS12219A; 7) Universal Block Tray - RX, Part Number AMS12381B.. 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. Quantity: 580 kits. 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.
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Safety Guide
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