AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIOngoing
Summary: Windstone Medical Packaging, Inc. is recalling AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B. Reason: Windstone Medical Packaging recalled specific items and lots of 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 is being recalled
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
Why
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia, Washington)
How to tell if yours is affected
UDI/DI B098DDS1159B0, Lot Numbers: 214412.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2816-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 17, 2026 |
| Reported | August 5, 2026 |
| Company | Windstone Medical Packaging, Inc. |
| Company location | Billings, MT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 24 kits |
More recalls from Windstone Medical Packaging, Inc. · all medical device recalls · recalls from June 2026