# FDA recall Z-2799-2026

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

## Product

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:    1)	ENT Pack, Part Number AMS10411B;   2)	ENT Pack, Part Number AMS10411C;   3)	Rhinoplasty Pack, Part Number AMS11963A;   4)	Spine Pack, Part Number AMS12636C;   5)	Lumbar Lami Pack, Part Number AMS12731;   6)	Septoplasty Pack, Part Number AMS13150;   7)	Septoplasty Pack, Part Number AMS13150A;   8)	Septoplasty Pack, Part Number AMS13150B;   9)	Rhinoplasty Pack, Part Number AMS14496A;   10)	Rhinoplasty Pack, Part Number AMS14496B;   11)	Rhinoplasty Pack, Part Number AMS14496C;   12)	Laryngoscopy Pack, Part Number AMS14736;   13)	Nasal and Sinus Pack, Part Number AMS16417;   14)	Major Pack, Part Number AMS16586;   15)	Major Pack, Part Number AMS16586A;   16)	Nasal and Sinus Pack, Part Number AMS7619A;   17)	Sinus Pack, Part Number AMS7819A.

## 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-2799-2026
- **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-2799-2026

## Citation

> AI Analytics. FDA recall Z-2799-2026. Retrieved 2026-09-02 from https://api.ai-analytics.org/recall/Z-2799-2026. Source: US FDA. Licensed CC0.

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