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FDAClass I · Medical device · Recalled July 8, 2026
A M S recall — Windstone Medical Packaging, Inc.
Hazard: 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.
Class I: most serious — reasonable probability of serious health consequences or death.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2621-2026
- Brand
- Windstone Medical Packaging
- Classification
- Class I
- Units affected
- 200 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Affected products
Companies & origin
- Recalling firm location
- Billings, MT, United States
- Firm address
- 1602 4th Ave N, N/A, 59101-1521
Identifying details (verbatim from the notice)
- Product codes / lots
- 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.
- Distribution
- US Nationwide distribution in the states of PA, GA, CA, WA.
- Firm notified the public via
- N/A
- FDA event ID
- 99189
- Recall initiated
- May 21, 2026
- FDA classified
- July 1, 2026
- FDA report date
- July 8, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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