AMS ALIGNED MEDICAL SOLUTIONS Kits Recall Issued
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Windstone Medical Packaging, Inc. is recalling 7306 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 they contain specific lots of Ritmed Neurological Sponges Non-Sterile recalled by Medicom due to potential for unexpected variability of endotoxin levels.
Which Products Are Affected
The recall covers 14 pack types distributed nationwide in AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, and WA. Affected products include:
- Laminectomy Pack, Pack Number AMS13574A (lots 235911, 236897)
- ACDF/Fusion Pack, Pack Number AMS14710B (lots 224717, 230666, 213914, 236351)
- Spine Pack, Pack Number AMS14991A (lots 215450, 230108)
- Spine Pack, Pack Number AMS14991B (lot 233346)
- Spinal Pack, Pack Number AMS16278 (lots 219872, 222999, 226497, 229309, 236465, 237544, 238613)
- Spine Pack, Pack Number AMS16499 (multiple lots listed)
- Spine Pack, Pack Number AMS16709 (lots 223361, 225039, 236666, 240344, 241412)
- Lumbar Spine Pack, Pack Number AMS17336 (lots 233541, 240967)
- Laminectomy Pack, Pack Number AMS17945 (lots 235478, 240779, 241565)
- Anterior Cervical Pack, Pack Number AMS17946 (lots 235954, 239092, 241514)
- Spine Pack, Pack Number AMS3150F (multiple lots)
- Spine Pack, Pack Number AMS3150G (lot 242374)
- Spine Pack, Pack Number AMS5451D (multiple lots)
- ENT Pack, Pack Number AMS9771 (multiple lots) All units total 7306. Recall number Z-2802-2026. Classification: Class II.
What You Should Do
Consumers should verify pack numbers, lot numbers, and UDIs against the listed affected products.
Why This Matters
The recall affects medical devices distributed across 14 states with potential variability in endotoxin levels.
Source
FDA recall Z-2802-2026; https://www.fda.gov
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 (1,767 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.