Recall Z-2802-2026 ยท OJH Orthopedic Tray
Windstone Medical Packaging, Inc.
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)
| Date | Jul 24, 2026 (initiated Jun 8, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Material/Component Contamination |
| Action | Aligned Medical Solutions (AMS) issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 6/8/2026 via email. The notice explained the issue, potential risk, and requested the following actions: identify and quarantine affected product, affix the sticker which reads: "RECALL NOTICE Medicom announced the recall of Ritmed Neurological Sponges contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall." " At the time the kit is opened for use any Medicom-Ritmed Neurological Sponges should be identified and set aside. |
| Quantity | 7306 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.