FDA Devices recall · Reported June 2, 2021
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).
Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Welch Allyn Inc recalled ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Mode… - a moderate-severity action.
ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Mode… was recalled by Welch Allyn Inc in June 2, 2021. Reason: Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and…. Check the official notice for the remedy. Verify recall #Z-1673-2021 with the FDA Devices before acting.
The recall
Welch Allyn Inc issued this moderate-severity FDA Devices recall-Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and….
- Moderate
- severity level
- 120K units
- affected scope
- Class II
- classification
- June 2, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1673-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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).
Reason for recall
Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1673-2021 |
| Date reported | June 2, 2021 |
| Date initiated | April 22, 2021 |
| Recalling firm | Welch Allyn Inc |
| Firm location | Skaneateles Falls, NY |
| Affected scope | 119770 units |
| Distribution | Worldwide - US Nationwide distribution Foreign: Afghanistan Albania Algeria American Samoa Argentina Australia Austria Azerbaijan Bahamas (the) Bahrain Bangladesh Barbados Belgium Bermuda Bhutan Bolivia (Plurinational Stat… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1673-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026