# FDA recall Z-0316-2021

> **GE Healthcare, LLC** · Class II · device recall initiated 2020-09-17.

## Product

Flow Sensor Service Part, Catalog 2087640-001-S

## Reason for recall

Flow sensors could have damaged tubes in the form of small punctures or cuts.

## Distribution

U.S. states where product was distributed - AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI    Foreign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Israel, Italy, Kuwait, Latvia, Macedonia, Madagascar, Malaysia, Nicaragua, Panama, Qatar, Russia, Singapore, Slovenia, Spain, Thailand, Ukraine, United Kingdom

## Key facts

- **Recall number:** Z-0316-2021
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-17
- **Report date:** 2020-11-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0316-2021

## Citation

> AI Analytics. FDA recall Z-0316-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0316-2021. Source: US FDA. Licensed CC0.

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