AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6) Septoplasty Pack, Part Number AMS13150; 7) Septoplasty Pack, Part Number AMS13150A; 8) Septoplasty Pack, Part Number AMS13150B; 9) Rhinoplasty Pack, Part Number AMS14496A; 10) Rhinoplasty Pack, Part Number AMS14496B; 11) Rhinoplasty Pack, Part Number AMS14496C; 12) Laryngoscopy Pack, Part Number AMS14736; 13) Nasal and Sinus Pack, Part Number AMS16417; 14) Major Pack, Part Number AMS16586; 15) Major Pack, Part Number AMS16586A; 16) Nasal and Sinus Pack, Part Number AMS7619A; 17) Sinus Pack, Part Number AMS7819A.
FDA Recall Z-2799-2026 · Posted 2026-07-24
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Recalling FirmWindstone Medical Packaging, Inc.
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2026-06-08
Product Quantity465 units
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.
Firm 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.
" 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: [email protected] even if you have no affected product on hand.
Those further distributing the product were directed to notify their distribution partners.
For questions contact [email protected].
Root Cause
Material/Component Contamination
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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