FDAFDA recall Z-2622-2026 · Jul 8, 2026
Windstone Medical Packaging, Inc.: A M S recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- 45 units
- Distribution
- US Nationwide distribution in the states of PA, GA, CA, WA.
- Recalling firm
- Windstone Medical Packaging, Inc., Billings, MT
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-21
Source: openFDA enforcement record Z-2622-2026 · search recall number Z-2622-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.