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
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
These labels are deterministic app interpretations, not FDA categories.
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
Code information
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Distribution pattern
Worldwide distribution - US Nationwide distribution.
device · product 2 of 4
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
These labels are deterministic app interpretations, not FDA categories.
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
Code information
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Distribution pattern
Worldwide distribution - US Nationwide distribution.
device · product 3 of 4
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
These labels are deterministic app interpretations, not FDA categories.
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
Code information
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Distribution pattern
Worldwide distribution - US Nationwide distribution.
device · product 4 of 4
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
These labels are deterministic app interpretations, not FDA categories.
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
Code information
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
Distribution pattern
Worldwide distribution - US Nationwide distribution.
