Windstone Medical Packaging Recalls AMS ENT Packs
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Windstone Medical Packaging, Inc. is recalling 919 units of AMS ALIGNED MEDICAL SOLUTIONS ENT Packs due to potential endotoxin variability from included Medicom 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 due to a Medicom Urgent Medical Device Recall of Ritmed Neurological Sponges Non-Sterile. The sponges may have unexpected variability of endotoxin levels.
Which Products Are Affected The recall covers 919 units distributed nationwide in AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, and WA. Affected products are:
- ENT Pack, Pack Number AMS12206 (UDI B098AMS122060), lots: 201002, 205119, 206649, 211870, 215233, 217552, 218967, 219166, 222076, 224914, 227000, 228485, 230336, 231348, 232214, 238290, 239795, 241802
- ENT Pack, Pack Number AMS15517 (UDI B098AMS155170), lots: 215924, 218494, 235207, 241105
- ENT Facial Pack, Pack Number AMS15863A (UDI B098AMS15863A0), lots: 229370, 235320, 235699, 237597, 239311, 241458 Recall number Z-2800-2026, Class II, initiated June 8, 2026.
What You Should Do Consumers should check lot numbers and contact Windstone Medical Packaging, Inc. for return or refund instructions.
Why This Matters The recall addresses potential variability in endotoxin levels in medical convenience kits distributed across multiple states.
Source FDA recall Z-2800-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (1,200 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 13, 2026.
Frequently Asked Questions
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