Recall Z-2620-2026— Windstone Medical Packaging, Inc.
Class I · Ongoing
Class I FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2026-05-21. FDA's recall record names no specific 510(k) clearance for this event. Product: A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit. Reason: 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..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-05-21
- Firm location
- Billings, MT, United States
Product description
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.