Welch Allyn ProBP 3400 Digital Blood Pressure Device Recall
Welch Allyn is recalling ProBP 3400 Digital Blood Pressure Devices due to a risk of fluid ingress causing electrical shorts and potential shock.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 electrical shock, which is a risk-of-harm product hazard where no specific injuries or illnesses have been reported in the source text, aligning with the 'High' severity criteria.
Plain-English summary
Welch Allyn Inc is recalling approximately 119,770 units of the ProBP 3400 Digital Blood Pressure Device, including handheld, desk mount, and wall mount models (Model 34XFHT-B). The recall covers all serial numbers and includes devices distributed worldwide and throughout the United States.
The recall is being issued because of a potential risk of fluid ingress to the power supplies. This condition could result in an internal electrical short, which poses a risk of electrical shock to users.
Consumers who possess these devices should stop using them immediately and contact Welch Allyn Inc for instructions on how to proceed with the recall.
The recalled product
- Product
- ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).
- Manufacturer
- Welch Allyn Inc
- Affected units
- 119,770
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Welch Allyn Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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