Class II
Medical Device Recall: 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.
Windstone Medical Packaging, Inc. · June 8, 2026
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.
Distribution
US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
States Affected
NATIONWIDE
Quantity Affected
919 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2800-2026
Status: ongoing
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