- Recalling firm
- Windstone Medical Packaging, Inc.
- 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.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 919 units
- Distribution pattern
- US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Firm location
- Billings, MT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2800-2026
- Recall initiated
- June 8, 2026
- FDA classification date
- July 24, 2026
- FDA report date
- August 5, 2026
- FDA event ID
- 99323
- Last updated on HTM Vibe
- August 11, 2026