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 2
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
These labels are deterministic app interpretations, not FDA categories.
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
Code information
UDI: PT - 000010 - 10385082000139; Lot Numbers: L000202
Distribution pattern
The products were distributed to the following foreign countries: Italy, Netherlands, UK.
device · product 2 of 2
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
These labels are deterministic app interpretations, not FDA categories.
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
Code information
UDI: PT000011 10385082000146; Lot Numbers: L000200, L000201, L000203, L000209, L000210
Distribution pattern
The products were distributed to the following foreign countries: Italy, Netherlands, UK.
