The affected products and recommendations for what to do with the devices below have not changed. 

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

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 NameModel NumberUDI-DI
DSAEK Pack - RXAMS12394BB098AMS12394B0
Thyroid FNA Pack - RXAMS17729B098AMS177290
Preop Kit - NSAMS18227B098AMS182270
Dr. Lewin PackAMS7200DB098AMS7200D0

Affected components contained within the convenience kits:

Component NameCardinal Health Part NumberAligned Medical Solutions Part NumberComponent Lot Number
Webcol Large Alcohol Prep Pad51106912425K006462

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.
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Reason for Correction

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

  1. FDA Enforcement Report
  2. CDRH Medical Device Recall Database
  3. Cardinal Health Large Alcohol Pad Recall: FDA Enforcement Report

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 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.

Timeline of Communication Updates

DateActions
07/06/2026The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall.
06/16/2026The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.