Class I

Medical Device Recall: A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit

Windstone Medical Packaging, Inc. · May 21, 2026

Reason for Recall

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.

Distribution

US Nationwide distribution in the states of PA, GA, CA, WA.

States Affected

NATIONWIDE

Quantity Affected

1080 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2619-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.