AMS Aligned Medical Solutions Neuro Packs Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Windstone Medical Packaging, Inc. is recalling 927 units of AMS medical convenience kits due to potential endotoxin variability in included sponges.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 13, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Windstone Medical Packaging, Inc. initiated a voluntary recall of certain AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits because the included Ritmed Neurological Sponges Non-Sterile may have unexpected variability of endotoxin levels.
Which Products Are Affected
The recall covers 927 units distributed nationwide in AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, and WA. Affected products include:
- Neuro Pack, Pack Number AMS12195C (UDI B098AMS12195C0), lots: 217757, 222686, 224418, 225587, 227439, 228598, 230569, 234138, 235331, 236869, 238356.
- Neuro Pack, Pack Number AMS12195D (UDI B098AMS12195D0), lot: 240974.
- Neuro Pack, Pack Number AMS12307 (UDI B098AMS12307), lots: 220948, 234027, 234756, 235909, 238000, 239036, 241680.
- Neuro Spine Pack, Pack Number AMS16313 (UDI B098AMS163130), lot: 241787.
- Lami Kukkar Pack, Pack Number AMS17958 (UDI B098AMS179580), lots: 235956, 237474.
- Neuro Pack, Pack Number AMS6452B (UDI B098AMS6452B0), lots: 212195, 217806, 220779, 222520, 223506, 224581, 225839, 226652, 227717, 233855, 234503, 236416, 240751.
- Neuro Lami Pack, Pack Number AMS9427C (UDI B098AMS9427C0), lots: 216097, 216766, 217573, 219221, 222013, 222070, 223714, 225092, 226568, 227813, 230393, 231091, 233313, 236502, 238280, 242405. Recall number Z-2801-2026, Class II, initiated June 8, 2026.
What You Should Do
Consumers should follow instructions provided in the Medicom Urgent Medical Device Recall notice referenced in the FDA recall.
Why This Matters
The recall addresses potential variability in endotoxin levels on neurological sponges included in the kits.
Source
FDA recall Z-2801-2026, Windstone Medical Packaging, Inc., Billings, MT.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,724 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.