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CLASS I · SeriousFDA

Windstone Medical Packaging, Inc. recalls A M S

📅 May 21, 2026 · 📍 Nationwide
Recalling company
Windstone Medical Packaging, Inc.
Product
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, 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.
Classification
Class I – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
May 21, 2026
Reported
Jul 8, 2026
Distribution
US Nationwide distribution in the states of PA, GA, CA, WA.
Status
Ongoing
Quantity
200 units
Lot / codes
UDI/DI none, Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313.
Company location
Billings, MT
Recall type
Voluntary: Firm initiated
Recall number
Z-2621-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2621-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.