FDA recall Z-2622-2026

Windstone Medical Packaging, Inc. · Class I · device

Product

A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, 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-2622-2026