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.
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Code information
UDI-DI: 10351688510686; Lot Number: 4371054
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
device · product 2 of 9
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Code information
Lot Number: 4387166
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Code information
Lot Number: 4380614, 4416451
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
device · product 4 of 9
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Code information
Lot Number: 4355397 4380735 4387234 4404740
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
device · product 5 of 9
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Code information
Lot Number: 4332915 4408772
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
device · product 6 of 9
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Code information
Lot Number: 4330826 4384397
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
device · product 7 of 9
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Code information
Lot Number: 4398428 4404690
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
device · product 8 of 9
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Code information
Lot Number: 4398433
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
device · product 9 of 9
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Code information
Lot Number: 4383431 4387987 4404698
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
