FDA recall Z-2619-2026

Windstone Medical Packaging, Inc. · Class I · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2026-05-21
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Billings, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2619-2026