Windstone Medical Packaging, Inc.: Neurological Tray

Recall Summary Windstone Medical Packaging is recalling seven neurological medical convenience kits that contain Ritmed Neurological Sponges because the sponges may have unpredictable levels of endotoxins (bacterial contaminants). These kits were distributed nationwide to healthcare facilities. The affected products include various Neuro Packs and related kits with specific pack numbers listed in the recall.

Recalling firm
Windstone Medical Packaging, Inc.
Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine Pack, Pack Number AMS16313; 5) Lami Kukkar Pack, Pack Number AMS17958; 6) Neuro Pack, Pack Number AMS6452B; 7) Neuro Lami Pack, Pack Number AMS9427C.
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/e43a4f08-f50e-4719-947d-cd2c43277770