Windstone Medical Packaging, Inc.: Ear, Nose, And Throat Surgical Tray
Recall Summary Three ENT surgical trays distributed by Windstone Medical Packaging are being recalled nationwide because they contain Ritmed Neurological Sponges with potentially unpredictable endotoxin levels, which could affect sterility. The recalled products are ENT Pack (AMS12206), ENT Pack (AMS15517), and ENT Facial Pack (AMS15863A). This is a Class I recall affecting medical facilities across the United States.
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.
- Reason
- The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-08
- 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 AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7c240cd8-8cbc-4541-885a-08e15b3f8679