Class IOngoingUpdated Nov 2, 2026
Windstone Medical Packaging, Inc. recalls 2 products
Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)
Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.
- Company
- Windstone Medical Packaging, Inc.
- 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.
- Hazard
- FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
- Who’s affected
- US Nationwide distribution in the states of PA, GA, CA, WA.
- Where
- Nationwide
- Official notice
- www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99189…
Products (2)
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
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.Quantity: 200 unitsRecall no. Z-2620-2026Class IA M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
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.Quantity: 45 unitsRecall no. Z-2622-2026Class I
Update history
- First listed on OVERLOOKED from the official record.
- Product details, codes or quantities changed; Units: 1080 kits; 200 units; 200 units; 45 units → 200 units; 45 units
When the agency expands or changes this recall, we update this page and log the change here.
Proof: raw official record (JSON) · fetched from FDA API
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