AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack

FDA device recall Z-2800-2026 · posted 2026-07-24 · Open, Classified

Recall details

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.

Action taken

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. " The recalled Medicom-Ritmed Neurological Sponges should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. Complete the recall reply form and return it via email to: fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand. Those further distributing the product were directed to notify their distribution partners. For questions contact fieldcorrectiveaction@alignedmedicalsolutions.com.

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

OGR

Quantity affected

919 units

Distribution

US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.

Date initiated

2026-06-08

Date posted

2026-07-24

Location

Billings, MT