FDAFDA · Food and drugs·Recall number Z-2619-2026
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Published July 8, 2026 · Recall initiated: May 21, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- US Nationwide distribution in the states of PA, GA, CA, WA.
- Lot
- UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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