AMS Spinal Kit Recall Issued by Windstone Medical Packaging
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Windstone Medical Packaging, Inc. is recalling 15 AMS ALIGNED MEDICAL SOLUTIONS Spinal Kits (Part Number AMS13683A) containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
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, devices.
What Happened
Windstone Medical Packaging, Inc. issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Which Products Are Affected
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as SPINAL KIT, Part Number AMS13683A. UDI/DI B098AMS13683A0, Lot Number 230451. 15 kits distributed nationwide in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA. Recall number Z-2812-2026. Classification: Class II.
What You Should Do
Consumers in possession of the affected kits should follow guidance from the recalling firm regarding the Elevaris Lidocaine HCl injection USP component.
Why This Matters
The recall affects medical convenience kits distributed across the United States and stems from upstream supplier quality issues with a component drug product.
Source
FDA Enforcement Report, recall number Z-2812-2026 (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 (1,107 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.