FDA Closes Recall of Medical Convenience Kits from Windstone Medical Packaging

The Food and Drug Administration considers the recall of 919 medical convenience kits carried out.

2 reports on this incident · first at Aug 20, 2026, 6:23 a.m. ET

By AI ReporterWritten Aug 20, 2026, 6:53 a.m. ET

The Food and Drug Administration has closed its action regarding a recall of medical convenience kits packaged by Billings-based , according to official agency records updated on August 5, 2026. Closing the action indicates that the FDA considers the recall carried out. The recall was originally initiated on June 8, 2026. The recall, recorded under recall number , involved distributed nationwide across Arizona, California, Connecticut, Georgia, Illinois, Massachusetts, Maryland, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Washington. Official records state the recall was initiated due to a Medicom Urgent Medical Device Recall of specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C because of potential unexpected variability of endotoxin levels. Under FDA definitions, a classification applies to products that may cause temporary or medically reversible adverse health consequences, and where the probability of serious adverse health consequences is remote. For anyone who still has the product, the affected AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits carry the following identifying codes: 1) ENT Pack, Pack Number AMS12206, UDI B098AMS122060, Lot Numbers: 215924, 218494, 235207, 241105; 2) ENT Pack, Pack Number AMS15517; and 3) ENT Facial Pack, Pack Number AMS15863A, UDI B098AMS15863A0, Lot Numbers: 229370, 235320, 235699, 237597, 239311, 241458. FDA database records show no other enforcement actions listed for

Earlier reports

Aug 20, 2026, 6:23 a.m. ETFirst report
FDA Reports Ongoing Recall of Medical Convenience Kits
On June 8, 2026, Windstone Medical Packaging, Inc., based in Billings, initiated a recall of 919 units of medical convenience kits, according to an FDA enforcement report issued on August 5, 2026. The recall remains ongoing.
The recall involves AMS ALIGNED MEDICAL SOLUTIONS products, including ENT Pack AMS12206 (UDI B098AMS122060; Lot Numbers 215924, 218494, 235207, 241105), ENT Pack AMS15517, and ENT Facial Pack AMS15863A (UDI B098AMS15863A0; Lot Numbers 229370, 235320, 235699, 237597, 239311, 241458). Distribution occurred nationwide across AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, and WA.
According to FDA enforcement record Z-2800-2026, the firm initiated the action due to a Medicom Urgent Medical Device Recall involving specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C over potential unexpected variability of endotoxin levels. The FDA classified the event as Class II, a category designated for products that may cause temporary or medically reversible health consequences or where the chance of serious harm is remote. FDA records list no other enforcement actions for Windstone Medical Packaging, Inc.

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Revision history

Version 120 Aug 2026, 10:23current
First published.
Version 120 Aug 2026, 10:53current
First published.

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