CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Windstone Medical Packaging, Inc., has issued a letter to affected customers recommending certain custom convenience kits be corrected prior to continued use by removing Cardinal Health Webcol large alcohol prep pads.
Affected convenience kits:
| Device Name | Model Number | UDI-DI |
|---|---|---|
| DSAEK Pack – RX | AMS12394B | B098AMS12394B0 |
| Thyroid FNA Pack – RX | AMS17729 | B098AMS177290 |
| Preop Kit – NS | AMS18227 | B098AMS182270 |
| Dr. Lewin Pack | AMS7200D | B098AMS7200D0 |
Affected components contained within the convenience kits:
| Component Name | Cardinal Health Part Number | Aligned Medical Solutions Part Number | Component Lot Number |
|---|---|---|---|
| Webcol Large Alcohol Prep Pad | 5110 | 69124 | 25K006462 |
Full List of Affected Products
What to Do
Apply the Aligned Medical Solutions over-label (see Recall Notice image below) to affected inventory. When the affected convenience kits are opened for use, remove, discard and do not use the Cardinal Health Webcol Alcohol Prep Pads.
On May 21, 2026, Aligned Medical Solutions sent all affected customers a letter recommending the following actions:
- Identify affected products.
- Apply the provided over-labels according to the instructions provided.
- When affected kits are opened for use, remove any Cardinal Health Alcohol Prep Pads.
- Mark on the removed pads that they are to be disposed of and set them aside for disposal.
- Dispose of the recalled pads following medical waste policies at your institution.
- Request replacement product as needed.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Windstone Medical Packaging initiated an Urgent Medical Device Recall notice for convenience kits that contain Cardinal Health alcohol pads affected by a Cardinal Health Nationwide Recall. The Alcohol Prep Pads may be contaminated with Paenibacillus phoenicis. Use of contaminated pads for skin preparation before injections or blood draws poses risk of infection to vulnerable groups such as critically ill, immunocompromised, neonatal, and pediatric patients.
As of June 4, 2026, Windstone Medical Packaging has reported no serious injuries or deaths associated with this issue.
Device Use
The convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Windstone Medical Packaging, Inc. at jjensen@alignedmedical.com or call (407) 638-9924.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database – Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
