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 16
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011008, Lot Numbers: 62040-A8375, 62040-A8432
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 2 of 16
VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011022, Lot Numbers: 62045-A8339, 62045-A8376, 62045-A8467
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 3 of 16
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011114, Lot Numbers: 64040-A8313, 64040-A8340, 64040-A8365, 64040-A8437
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 4 of 16
CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 5 of 16
CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011138, Lot Numbers: 64050-A8293, 64050-A8406, 64050-A8421, 64050-A8452, 64050-A8470
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 6 of 16
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011541, Lot Numbers: 66040-A8314, 66040-A8368, 66040-A8417, 66040-A8482
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 7 of 16
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 50812496011553, Lot Numbers: 66041-A8296, 66041-A8343, 66041-A8386, 66041-A8418, 66041-A8433
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 8 of 16
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011565, Lot Numbers: 66042-A8297, 66042-A8422, 66042-A8459
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 9 of 16
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 50812496011577, Lot Numbers: 66043-A8298
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 10 of 16
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011589, Lot Numbers: 66045-A8308, 66045-A8334, 66045-A8360, 66045-A8382, 66045-A8419
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 11 of 16
SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011596, Lot Numbers: 66050-A8335, 66050-A8409, 66050-A8460
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 12 of 16
SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011602, Lot Numbers: 66055-A8336, 66055-A8483
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 13 of 16
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011305, Lot Numbers: 68040-A8318, 68040-A8408, 68040-A8441, 68040-A8474
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 14 of 16
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011312, Lot Numbers: 68045-A8289, 68045-A8319, 68045-A8347, 68045-A8390, 68045-A8434
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 15 of 16
Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
A limited number of IV bags have been found to leak during filling.
Code information
UDI/DI 00812496011329, Lot Numbers: 68050-A8320, 68050-A8435, 68050-A8476
Distribution pattern
Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.
device · product 16 of 16
Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
