Recall Z-2622-2026— 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, Dr. Lewin Pack, Pack Number AMS7200D, 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, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.