# FDA recall Z-2802-2026

> **Windstone Medical Packaging, Inc.** · Class II · device recall initiated 2026-06-08.

## 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;   6)	Spine Pack, Pack Number AMS16499;   7)	Spine Pack, Pack Number AMS16709;   8)	Lumbar Spine Pack, Pack Number AMS17336;   9)	Laminectomy Pack, Pack Number AMS17945;   10)	Anterior Cervical Pack, Pack Number AMS17946;   11)	Spine Pack, Pack Number AMS3150F;   12)	Spine Pack, Pack Number AMS3150G;   13)	Spine Pack, Pack Number AMS5451D;   14)	ENT Pack, Pack Number AMS9771.

## Reason for recall

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

## Distribution

US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.

## Key facts

- **Recall number:** Z-2802-2026
- **Recalling firm:** Windstone Medical Packaging, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-08
- **Report date:** 2026-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billings, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2802-2026

## Citation

> AI Analytics. FDA recall Z-2802-2026. Retrieved 2026-08-31 from https://api.ai-analytics.org/recall/Z-2802-2026. Source: US FDA. Licensed CC0.

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