ProBP 3400 Digital Blood Pressure Device — Class II medical device recall Z-1673-2021

Terminated recall by Welch Allyn Inc, reported 2021-06-02, distributed nationwide. Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and p

Recall number	`Z-1673-2021`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Welch Allyn Inc, Skaneateles Falls, NY, United States
Recall initiated	2021-04-22
Classified	2021-05-21
Reported by FDA	2021-06-02
Terminated	2024-05-31
Distributed	Nationwide (US)
Countries outside the US	AE, AF, AR, AT, AU, BB, BD, BE, BG, BH, BM, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LU, LV, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, TT, TW, UA, VE, VN, ZA
Quantity	119,770 units
Model numbers	`34XFHT-B`

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).

Reason for recall

Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1673-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.