# FDA recall Z-0635-2024

> **Natus Medical Incorporated** · Class II · device recall initiated 2023-11-28.

## Product

EDS 3 CSF External Drainage System,  REF: NT821731C, STERILEEO, Rx only

## Reason for recall

Sterility assurance cannot be guaranteed for external drainage  systems due to incomplete bioburden testing.

## Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, 	IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV.

## Key facts

- **Recall number:** Z-0635-2024
- **Recalling firm:** Natus Medical Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-28
- **Report date:** 2024-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2024

## Citation

> AI Analytics. FDA recall Z-0635-2024. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0635-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*