Z-1777-2017Class II

Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China...

Name: Z-1777-2017 Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China...
Creator: Welch Allyn Inc
Published: 2017-02-27
License: https://open.fda.gov/license/

Welch Allyn Inc / initiated 2017-02-27 / Terminated

FDA source

Welch Allyn Inc began a recall of Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road... on 2017-02-27. FDA classified it as Class II and gives the reason as "A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1777-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-27
Posted: 2017-04-11
Terminated: 2019-06-14
Recalling firm: Welch Allyn Inc
Product: Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery. The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.
FDA root cause: Other
Action: Welch Allyn sent an Urgent Medical Device Recall letter and Response Forms dated February 21, 2017. They were mailed to the first round of customers beginning on Monday February 27, 2017, via US Postal Service Priority Mail. Welch Allyn will follow up with second round of mailings to the additionally identified end users the week of March 20, 2017. All end users will be instructed to confirm that their unit is affected; and if affected, a replacement unit will be provided so that the affected unit can be returned and scrapped. --- Of the 1120 units, a total of 981 units were distributed from Welch Allyn warehouses and 139 units remained under Welch Allyn control and were not distributed. These units have since been destroyed. For further questions, please call (844) 360-8220.
Quantity in commerce: 981 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution
Product codes and lots: Lot Number 0715: Serial Number range (21)07150001 - (21)07150620; Lot Number 1215: Serial Number range (21)12150001 - (21)12150500; --- Note: (21) is NOT part of the serial number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the serial number on any GUDI compliant label.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1777-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1777-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11

Product code DXN

K152770Class IIProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH / cleared 2015-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)