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 4
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
These labels are deterministic app interpretations, not FDA categories.
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Code information
All Serial Numbers
Distribution pattern
Worldwide distribution - US Nationwide and Global distribution.
device · product 2 of 4
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
These labels are deterministic app interpretations, not FDA categories.
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Code information
All Serial Numbers
Distribution pattern
Worldwide distribution - US Nationwide and Global distribution.
device · product 3 of 4
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
These labels are deterministic app interpretations, not FDA categories.
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Code information
All Serial Numbers
Distribution pattern
Worldwide distribution - US Nationwide and Global distribution.
device · product 4 of 4
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
These labels are deterministic app interpretations, not FDA categories.
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Code information
All Serial Numbers
Distribution pattern
Worldwide distribution - US Nationwide and Global distribution.
