FDA-Device2026-07-08Class IPROCESSING DEFECT
Windstone Medical AMS Preop Kit-NS recalled for bacterial contamination in alcohol prep pads
What this means
Windstone Medical's AMS Preop Kit-NS surgical convenience kits contain Webcol Large Alcohol Prep Pads that were recalled due to bacterial contamination (Paenibacillus phoenicis) discovered during sterilization testing. The contamination was identified by Cardinal Health, the pad manufacturer. About 200 kits with specific lot codes are affected.
- Check your kit's lot code against the FDA notice (lots 237663–241224, listed on FDA.gov)
- Do not use affected kits for surgical prep
- Contact your supplier or Windstone Medical for instructions on return or replacement
- Report any adverse events to the FDA MedWatch program
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of PA, GA, CA, WA.
Affected count
200 units
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2621-2026More Windstone Medical Packaging recalls
- FDA-Device2026-07-08A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
- FDA-Device2026-07-08A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
- FDA-Device2026-07-08A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
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