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 7
Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Code information
All Serial Numbers
Distribution pattern
Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. United Kingdom Uruguay Vatikancity Vietnam
device · product 2 of 7
Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Code information
All Serial Numbers
Distribution pattern
Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. United Kingdom Uruguay Vatikancity Vietnam
device · product 3 of 7
Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Code information
All Serial Numbers
Distribution pattern
Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. United Kingdom Uruguay Vatikancity Vietnam
device · product 4 of 7
Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Code information
All Serial Numbers
Distribution pattern
Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. United Kingdom Uruguay Vatikancity Vietnam
device · product 5 of 7
RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Code information
All Serial Numbers
Distribution pattern
Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. United Kingdom Uruguay Vatikancity Vietnam
device · product 6 of 7
RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Code information
All Serial Numbers
Distribution pattern
Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. United Kingdom Uruguay Vatikancity Vietnam
device · product 7 of 7
RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Code information
All Serial Numbers
Distribution pattern
Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. United Kingdom Uruguay Vatikancity Vietnam
