FDA Reports Ongoing Class II Recall of Medical Kits by Windstone Medical Packaging
An ongoing Class II recall involves 927 medical convenience kits distributed nationwide by Billings-based Windstone Medical Packaging, Inc.
By AI ReporterWritten Aug 20, 2026, 8:43 a.m. ET
On August 5, 2026, an official FDA enforcement report listed an recall for of medical convenience kits packaged by , located in . The recall was initially initiated on June 8, 2026, and remains open and developing. is the FDA's middle recall category, used where a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote.
According to the FDA enforcement report, the recall covers AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits distributed nationwide across AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, and WA. The specific recalled kits, pack numbers, UDIs, and lot numbers are:
- Neuro Pack, Pack Number AMS12195C (UDI B098AMS12195C0; Lot Numbers: 217757, 222686, 224418, 225587, 227439, 228598, 230569, 234138, 235331, 236869, 238356)
- Neuro Pack, Pack Number AMS12195D (UDI B098AMS12195D0; Lot Number: 240974)
- Neuro Pack, Pack Number AMS12307 (UDI B098AMS12307; Lot Numbers: 220948, 234027, 234756, 235909, 238000, 239036, 241680)
- Neuro Spine Pack, Pack Number AMS16313 (UDI B098AMS163130; Lot Number: 241787)
- Lami Kukkar Pack, Pack Number AMS17958 (UDI B098AMS179580; Lot Numbers: 235956, 237474)
- Neuro Pack, Pack Number AMS6452B (UDI B098AMS6452B0; Lot Numbers: 212195, 217806, 220779, 222520, 223506, 224581, 225839, 226652, 227717, 233855, 234503, 236416, 240751)
- Neuro Lami Pack, Pack Number AMS9427C (UDI B098AMS9427C0; Lot Numbers: 216097, 216766, 217573, 219221, 222013, 222070, 223714, 225092, 226568, 227813, 230393, 231091, 233313, 236502, 238280, 242405)
The recall notice (recall number ) was initiated due to a Medicom Urgent Medical Device Recall of specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C, caused by potential unexpected variability of endotoxin levels on the products. FDA enforcement records show no prior recall history for
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