Windstone Medical Packaging, Inc.: Orthopedic Tray
Recall Summary Windstone Medical Packaging is recalling 14 different orthopedic surgical kits (spine, laminectomy, fusion, and ENT packs) distributed nationwide because they contain Ritmed Neurological Sponges with potentially unpredictable endotoxin levels, which are non-sterile materials used in spinal and neurological surgeries. This is a Class I recall, the most serious classification. The affected kits were distributed to medical facilities across the United States.
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278; 6) Spine Pack, Pack Number AMS16499; 7) Spine Pack, Pack Number AMS16709; 8) Lumbar Spine Pack, Pack Number AMS17336; 9) Laminectomy Pack, Pack Number AMS17945; 10) Anterior Cervical Pack, Pack Number AMS17946; 11) Spine Pack, Pack Number AMS3150F; 12) Spine Pack, Pack Number AMS3150G; 13) Spine Pack, Pack Number AMS5451D;...
- 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/35e04886-fa29-42f4-8c2a-db58de5b6fd6