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-2622-2026
Brand: Windstone Medical Packaging
Classification: Class I
Units affected: 45 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit

Affected products

A M S

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 24, 2026 at 12:00 AM UTC.

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