FDAFDA recall Z-2800-2026 · Aug 5, 2026
Windstone Medical Packaging, Inc.: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack recall
Recall found
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 for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- 919 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Recalling firm
- Windstone Medical Packaging, Inc., Billings, MT
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-08
Source: openFDA enforcement record Z-2800-2026 · search recall number Z-2800-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.