The Recall Desk
HighFDA (Devices)·Z-2802-2026·Announced 2026-08-05

Medical convenience kits recalled due to potential endotoxin level variability

Windstone Medical Packaging, Inc. is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits because of potential unexpected variability in endotoxin levels.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves medical devices with a high-risk hazard (endotoxin variability) where injury has not yet been reported, which falls under the High severity category.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling specific lots of AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits. These kits include various packs such as Laminectomy, ACDF/Fusion, Spine, Spinal, Lumbar Spine, Anterior Cervical, and ENT packs.

The recall was initiated due to potential unexpected variability of endotoxin levels on the products. This affects 7,306 units distributed nationwide in AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, and WA.

Specific affected pack numbers and lot numbers include: Laminectomy Pack (AMS13574A, AMS17945), ACDF/Fusion Pack (AMS14710B), Spine Packs (AMS14991A, AMS14991B, AMS16499, AMS16709, AMS3150F, AMS3150G, AMS5451D), Spinal Pack (AMS16278), Lumbar Spine Pack (AMS17336), Anterior Cervical Pack (AMS17946), and ENT Pack (AMS9771).

The recalled product

Product
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278;
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Medical Convenience Kits
Hazard
Affected units
7,306

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) Pack Number AMS13574A
  • UDI B098AMS13574A0
  • Lot Numbers: 235911
  • 236897. 2) Pack Number AMS14710B
  • UDI B098AMS14710B0
  • Lot Numbers: 224717
  • 230666
  • 213914
  • 236351. 3) Pack Number AMS14991A
  • UDI B098AMS14991A0
  • Lot Numbers: 215450
  • 230108. 4) Pack Number AMS14991B
  • UDI B098AMS14991B0
  • Lot Numbers: 233346. 5) Pack Number AMS16278
  • UDI B098AMS162780
  • Lot Numbers: 219872
  • 222999
  • 226497
  • 229309
  • 236465

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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Same manufacturer · Windstone Medical Packaging, Inc.

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