# FDA recall Z-1519-2021

> **Oto Med Inc** · Class II · device recall initiated 2020-12-07.

## Product

Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage:  intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

## Reason for recall

During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of MN, IL, PA, WI, GA, SD, FL, AR, MA, AZ, TX, MO, NC, CA, UT, DE, OR, IN, CO, AL, OH, NY, WA, DC, TN, NH, VT, VA, SC, MI, WI, MS, IA, NJ, MD, KS, CT, LA, ME, KY, HI, TN, RI, NV, ID and the countries of Argentina, Brazil, Colombia, Chile, Hong Kong, South Africa, United Arab Emirates, Taiwan, Canada, India.

## Key facts

- **Recall number:** Z-1519-2021
- **Recalling firm:** Oto Med Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-07
- **Report date:** 2021-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Havasu City, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1519-2021

## Citation

> AI Analytics. FDA recall Z-1519-2021. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-1519-2021. Source: US FDA. Licensed CC0.

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