Windstone Medical Packaging Recalls AMS Medical Convenience Kits
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Windstone Medical Packaging, Inc. is recalling 465 units of 17 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits due to potential endotoxin variability from 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 due to a Medicom Urgent Medical Device Recall of Ritmed Neurological Sponges Non-Sterile models due to potential for unexpected variability of endotoxin levels on the products.
Which Products Are Affected
The recall affects 465 units of the following AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits distributed nationwide in AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, and WA:
- ENT Pack, Part Number AMS10411B
- ENT Pack, Part Number AMS10411C
- Rhinoplasty Pack, Part Number AMS11963A
- Spine Pack, Part Number AMS12636C
- Lumbar Lami Pack, Part Number AMS12731
- Septoplasty Pack, Part Number AMS13150
- Septoplasty Pack, Part Number AMS13150A
- Septoplasty Pack, Part Number AMS13150B
- Rhinoplasty Pack, Part Number AMS14496A
- Rhinoplasty Pack, Part Number AMS14496B
- Rhinoplasty Pack, Part Number AMS14496C
- Laryngoscopy Pack, Part Number AMS14736
- Nasal and Sinus Pack, Part Number AMS16417
- Major Pack, Part Number AMS16586
- Major Pack, Part Number AMS16586A
- Nasal and Sinus Pack, Part Number AMS7619A
- Sinus Pack, Part Number AMS7819A Specific lot numbers and UDI codes for each are listed in the recall. Recall number Z-2799-2026. Classification: Class II.
What You Should Do
No specific consumer action steps are provided in the recall notice.
Why This Matters
This Class II recall involves 465 units of medical kits distributed across 14 states due to potential variability in endotoxin levels.
Source
FDA recall Z-2799-2026
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 (1,581 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.