# FDA recall Z-0531-2021

> **Verathon, Inc.** · Class II · device recall initiated 2020-09-29.

## Product

BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.

## Reason for recall

Due to a change in handle material and process, probe handle may crack.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WI, WV and WY.    The countries of Austrailia, Belgium, Canada, France, Germany, Kuwait, Luxembourg, New Zealand, Portugal, Singapore, Sweden, Switzerland, Taiwan, and United Kingdom.

## Key facts

- **Recall number:** Z-0531-2021
- **Recalling firm:** Verathon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-29
- **Report date:** 2020-12-09
- **Termination date:** 2022-06-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0531-2021

## Citation

> AI Analytics. FDA recall Z-0531-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0531-2021. Source: US FDA. Licensed CC0.

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