FDA Medical devices recall ·
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT… recall
- Recall number
- Z-2800-2026
- Date
- (initiated June 8, 2026)
- Company / brand
- Windstone Medical Packaging, Inc.
1602 4th Ave N, Billings, MT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 919 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) Pack Number AMS12206, UDI B098AMS122060, Lot Numbers: 201002, 205119, 206649, 211870, 215233, 217552, 218967, 219166, 222076, 224914, 227000, 228485, 230336, 231348, 232214, 238290, 239795, 241802. 2) Pack Number AMS15517, UDI B098AMS155170, Lot Numbers: 215924, 218494, 235207, 241105. 3) Pack Number AMS15863A, UDI B098AMS15863A0, Lot Numbers: 229370, 235320, 235699, 237597, 239311, 241458.
Distribution
US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
States: Arizona California Connecticut Georgia Illinois Massachusetts Maryland New York Ohio Pennsylvania Tennessee Texas Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2800-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.