Windstone Medical Packaging, Inc.: General Surgery Tray
Recall Summary Windstone Medical Packaging is recalling General Surgery Trays (AMS brand, Pack Number AMS12394B) because they contain Webcol Large Alcohol Prep Pads that were contaminated with bacteria (Paenibacillus phoenicis) discovered during sterilization testing. The kits were distributed nationwide, primarily in Pennsylvania, Georgia, California, and Washington. This is classified as a Class II recall, meaning the product could potentially cause adverse health effects.
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of PA, GA, CA, WA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/33def619-9387-4af4-84e4-31f693dd04ac