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 3
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
These labels are deterministic app interpretations, not FDA categories.
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Code information
UDI-DI: (01)00850030354006; Lot Number: 11428361, 11393260, 11395226
Distribution pattern
US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
device · product 2 of 3
HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
These labels are deterministic app interpretations, not FDA categories.
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Code information
UDI-DI: (01)00862559000463; Lot Number: 11389279, 11391525
Distribution pattern
US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
device · product 3 of 3
HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
These labels are deterministic app interpretations, not FDA categories.
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Code information
UDI-DI: (01)00862559000456; Lot Number: 11398679, 11416178
Distribution pattern
US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
