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.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 699073130013 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
device · product 2 of 14
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 57599000101 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 57599080000 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 456074613 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 8290320122 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 8627005303 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 328785101508 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
device · product 8 of 14
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 353885009713 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 353885393102 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
device · product 10 of 14
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 353885994255 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 812608030026 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 812608030019 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
device · product 13 of 14
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 8373982700 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
device · product 14 of 14
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
These labels are deterministic app interpretations, not FDA categories.
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Code information
NDC/UPC: 365702493100 All lots shipped from 2/23/201 to 3/10/2021
Distribution pattern
US Nationwide distribution in the states of FL, GA, SC.
