FDA Recalls medium

AMS Aligned Medical Solutions Kits Recall

Source: FDA · United States

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 3,378 AMS convenience kits 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 lots of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the lidocaine due to supplier quality issues. The recall is classified as Class II and is ongoing.

Which Products Are Affected

The recall affects 3,378 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, and WA. Affected products include:

  1. Loop Recorder Pack 2 -RX, Part Number AMS10164, UDI/DI B098AMS101640, Lot Numbers: 230816
  2. NY Tray - RX, Part Number AMS10276A, UDI/DI B098AMS10276A0, Lot Numbers: 230588, 230589, 230590, 230893, 241165
  3. NYC Tray - RX, Part Number AMS10281B, UDI/DI B098AMS10281B0, Lot Numbers: 215784, 231259, 241171
  4. Vein Pack - RX, Part Number AMS11398C, UDI/DI B098AMS11398C0, Lot Numbers: 230680
  5. Radiology Tray-RX, Part Number AMS1217A, UDI/DI B098AMS1217A0, Lot Numbers: 217313
  6. Custom Pack - RX, Part Number AMS12757B, UDI/DI B098AMS12757B0, Lot Numbers: 240360
  7. Biopsy Tray w/Lidocaine - RX, Part Number AMS13700, UDI/DI B098AMS137000, Lot Numbers: 217431
  8. Arthrogram Tray - RX, Part Number AMS13755A, UDI/DI B098AMS13755A0, Lot Numbers: 230376, 241103
  9. Myelogram Tray - RX, Part Number AMS14805A, UDI/DI B098AMS14805A0, Lot Numbers: 217790
  10. Arthrogram Tray - RX, Part Number AMS15071A, UDI/DI B098AMS15071A0, Lot Numbers: 230689
  11. Vein Pack - RX, Part Number AMS15270, UDI/DI B098AMS152700, Lot Numbers: 230667
  12. Myelogram Tray - RX, Part Number AMS15298, UDI/DI B098AMS152980, Lot Numbers: 216398
  13. Loop Pack - RX, Part Number AMS15643, UDI/DI B098AMS156430, Lot Numbers: 241219
  14. Basic Biopsy Tray - RX, Part Number AMS15662A, UDI/DI B098AMS15662A0, Lot Numbers: 241307
  15. Pain Pack -RX, Part Number AMS17021, UDI/DI B098AMS170210, Lot Numbers: 230737, 231023
  16. Pain Tray -RX, Part Number AMS17817, UDI/DI B098AMS178170, Lot Numbers: 241136
  17. Vasectomy Pack - RX, Part Number AMS18226, UDI/DI B098AMS182260, Lot Numbers: 241031
  18. Arthrogram Tray- RX, Part Number AMS2886(A, UDI/DI B098AMS2886(A0, Lot Numbers: 230745
  19. Custom Pack - RX, Part Number AMS3081C, UDI/DI B098AMS3081C0, Lot Numbers: 230716
  20. Basic Procedure Pack - RX, Part Number AMS5497, UDI/DI B098AMS54970, Lot Numbers: 230851
  21. Basic Pack - RX, Part Number AMS8130C, UDI/DI B098AMS8130C0, Lot Numbers: 217634, 217635, 231235, 231236, 240963
  22. Supply Kit - RX, Part Number AMS9521A, UDI/DI B098AMS9521A0, Lot Numbers: 217055
  23. Maximal Sterile Barrier Vascular Access Procedure Kit - RX, Part Number VK0003MB, UDI/DI 00813623010666, Lot Numbers: 217429

Recall number: Z-2818-2026. Recalling firm: Windstone Medical Packaging, Inc., 1602 4th Ave N, Billings, MT 59101-1521.

What You Should Do

Consumers should verify product part numbers, lot numbers, and UDI/DI against the recalled list.

Why This Matters

The recall involves 3,378 medical convenience kits distributed across 22 states that contain lidocaine subject to supplier quality issues.

Source

FDA recall number Z-2818-2026, report date 20260805.

Original source: FDA Official Notice ↗

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Similar severity timing

Same severity (medium) notices issued closest in time to August 13, 2026.

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about? ▾
Windstone Medical Packaging, Inc. is recalling 3,378 AMS convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues.
Which agency issued this alert? ▾
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert? ▾
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected? ▾
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates? ▾
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.

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