openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings.
Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Code information
All serial numbers
Distribution pattern
Worldwide - US Nationwide distribution Foreign: Afghanistan Albania Algeria American Samoa Argentina Australia Austria Azerbaijan Bahamas (the) Bahrain Bangladesh Barbados Belgium Bermuda Bhutan Bolivia (Plurinational State of) Botswana Brazil Brunei Darussalam Bulgaria Cameroon Canada Chad Chile China Colombia Congo (the Democratic Republic of the) Congo (the) Costa Rica Croatia Cyprus Czechia Denmark Dominican Republic (the) Ecuador Egypt El Salvador Estonia Eswatini Finland France French Polynesia Georgia Germany Ghana Greece Guam Guatemala Honduras Hong Kong Hungary Iceland India Indonesia Iran (Islamic Republic of) Iraq Ireland Israel Italy Jamaica Japan Jordan Kenya Korea (the Republic of) Kuwait Lao People's Democratic Republic (the) Latvia Lebanon Lesotho Libya Luxembourg Malaysia Maldives Malta Mexico Mozambique Myanmar Namibia Nepal Netherlands (the) New Zealand Nicaragua Nigeria Northern Mariana Islands (the) Norway Oman Pakistan Panama Paraguay Peru Philippines (the) Poland Portugal Puerto Rico Qatar R¿union Romania Russian Federation (the) Saudi Arabia Senegal Serbia Singapore Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan (Province of China) Thailand Trinidad and Tobago Tunisia Turkey Uganda Ukraine United Arab Emirates (the) United Kingdom Venezuela (Bolivarian Republic of) Viet Nam
device · product 2 of 2
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
Code information
All serial numbers
Distribution pattern
Worldwide - US Nationwide distribution Foreign: Afghanistan Albania Algeria American Samoa Argentina Australia Austria Azerbaijan Bahamas (the) Bahrain Bangladesh Barbados Belgium Bermuda Bhutan Bolivia (Plurinational State of) Botswana Brazil Brunei Darussalam Bulgaria Cameroon Canada Chad Chile China Colombia Congo (the Democratic Republic of the) Congo (the) Costa Rica Croatia Cyprus Czechia Denmark Dominican Republic (the) Ecuador Egypt El Salvador Estonia Eswatini Finland France French Polynesia Georgia Germany Ghana Greece Guam Guatemala Honduras Hong Kong Hungary Iceland India Indonesia Iran (Islamic Republic of) Iraq Ireland Israel Italy Jamaica Japan Jordan Kenya Korea (the Republic of) Kuwait Lao People's Democratic Republic (the) Latvia Lebanon Lesotho Libya Luxembourg Malaysia Maldives Malta Mexico Mozambique Myanmar Namibia Nepal Netherlands (the) New Zealand Nicaragua Nigeria Northern Mariana Islands (the) Norway Oman Pakistan Panama Paraguay Peru Philippines (the) Poland Portugal Puerto Rico Qatar R¿union Romania Russian Federation (the) Saudi Arabia Senegal Serbia Singapore Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan (Province of China) Thailand Trinidad and Tobago Tunisia Turkey Uganda Ukraine United Arab Emirates (the) United Kingdom Venezuela (Bolivarian Republic of) Viet Nam
