AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX...
FDA Device Recall #Z-2818-2026 - Class II, June 17, 2026
Recall Summary
| Recall Number | Z-2818-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | June 17, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Windstone Medical Packaging, Inc. |
| Location | Billings, MT |
| Product Type | Devices |
| Quantity | 3378 kits |
Product Description
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B; 4) Vein Pack - RX, Part Number AMS11398C; 5) Radiology Tray-RX, Part Number AMS1217A; 6) Custom Pack - RX, Part Number AMS12757B; 7) Biopsy Tray w/Lidocaine - RX, Part Number AMS13700; 8) Arthrogram Tray - RX, Part Number AMS13755A; 9) Myelogram Tray - RX, Part Number AMS14805A; 10) Arthrogram Tray - RX, Part Number AMS15071A; 11) Vein Pack - RX, Part Number AMS15270; 12) Myelogram Tray - RX, Part Number AMS15298; 13) Loop Pack - RX, Part Number AMS15643; 14) Basic Biopsy Tray - RX, Part Number AMS15662A; 15) Pain Pack -RX, Part Number AMS17021; 16) Pain Tray -RX, Part Number AMS17817; 17) Vasectomy Pack - RX, Part Number AMS18226; 18) Arthrogram Tray- RX, Part Number AMS2886(A; 19) Custom Pack - RX, Part Number AMS3081C; 20) Basic Procedure Pack - RX, Part Number AMS5497; 21) Basic Pack - RX, Part Number AMS8130C; 22) Supply Kit - RX, Part Number AMS9521A; 23) Maximal Sterile Barrier Vascular Access Procedure Kit - RX, Part Number VK0003MB.
Reason for Recall
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.
Distribution Pattern
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.
Lot / Code Information
Part Number AMS10164, UDI/DI B098AMS101640, Lot Numbers: 230816; Part Number AMS10276A, UDI/DI B098AMS10276A0, Lot Numbers: 230588, 230589, 230590, 230893, 241165; Part Number AMS10281B, UDI/DI B098AMS10281B0, Lot Numbers: 215784, 231259, 241171; Part Number AMS11398C, UDI/DI B098AMS11398C0, Lot Numbers: 230680; Part Number AMS1217A, UDI/DI B098AMS1217A0, Lot Numbers: 217313; Part Number AMS12757B, UDI/DI B098AMS12757B0, Lot Numbers: 240360; Part Number AMS13700, UDI/DI B098AMS137000, Lot Numbers: 217431; Part Number AMS13755A, UDI/DI B098AMS13755A0, Lot Numbers: 230376, 241103; Part Number AMS14805A, UDI/DI B098AMS14805A0, Lot Numbers: 217790; Part Number AMS15071A, UDI/DI B098AMS15071A0, Lot Numbers: 230689; Part Number AMS15270, UDI/DI B098AMS152700, Lot Numbers: 230667; Part Number AMS15298, UDI/DI B098AMS152980, Lot Numbers: 216398; Part Number AMS15643, UDI/DI B098AMS156430, Lot Numbers: 241219; Part Number AMS15662A, UDI/DI B098AMS15662A0, Lot Numbers: 241307; Part Number AMS17021, UDI/DI B098AMS170210, Lot Numbers: 230737, 231023; Part Number AMS17817, UDI/DI B098AMS178170, Lot Numbers: 241136; Part Number AMS18226, UDI/DI B098AMS182260, Lot Numbers: 241031; Part Number AMS2886(A, UDI/DI B098AMS2886(A0, Lot Numbers: 230745; Part Number AMS3081C, UDI/DI B098AMS3081C0, Lot Numbers: 230716; Part Number AMS5497, UDI/DI B098AMS54970, Lot Numbers: 230851; Part Number AMS8130C, UDI/DI B098AMS8130C0, Lot Numbers: 217634, 217635, 231235, 231236, 240963; Part Number AMS9521A, UDI/DI B098AMS9521A0, Lot Numbers: 217055; Part Number VK0003MB, UDI/DI 00813623010666, Lot Numbers: 217429.
Other Recalls from Windstone Medical Packaging, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2812-2026 | Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenien... | Jun 17, 2026 |
| Z-2819-2026 | Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenien... | Jun 17, 2026 |
| Z-2814-2026 | Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenien... | Jun 17, 2026 |
| Z-2816-2026 | Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenien... | Jun 17, 2026 |
| Z-2817-2026 | Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenien... | Jun 17, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.