The Recall Desk
HighFDA (Devices)·Z-0531-2021·Announced 2020-12-09

Verathon BladderScan Prime Plus Probe Recall for Handle Cracking Risk

Verathon is recalling 398 BladderScan Prime Plus Probes because a change in handle material and process may cause the handle to crack.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the handle may crack, but the source text does not report any injuries or illnesses.

Plain-English summary

Verathon, Inc. is recalling 398 units of the BladderScan Prime Plus Probe (REF 0570-0395). This medical device is intended to be used for measuring the urine volume in the bladder noninvasively.

The recall is being conducted because a change in the handle material and process may cause the probe handle to crack. The affected units were distributed worldwide, including nationwide distribution in the United States and in Australia, Belgium, Canada, France, Germany, Kuwait, Luxembourg, New Zealand, Portugal, Singapore, Sweden, Switzerland, Taiwan, and the United Kingdom.

Consumers and healthcare facilities should stop using the affected probes and contact Verathon, Inc. for instructions on how to proceed.

The recalled product

Product
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Manufacturer
Verathon, Inc.
Hazard
Affected units
398

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically: