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.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
These labels are deterministic app interpretations, not FDA categories.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
These labels are deterministic app interpretations, not FDA categories.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Code information
1733850164 1805050064
Distribution pattern
The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
These labels are deterministic app interpretations, not FDA categories.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Code information
1733152764 1806451564
Distribution pattern
The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
These labels are deterministic app interpretations, not FDA categories.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Code information
1733952664 1735258064
Distribution pattern
The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
These labels are deterministic app interpretations, not FDA categories.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Code information
1813600164
Distribution pattern
The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
These labels are deterministic app interpretations, not FDA categories.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Code information
1814906864
Distribution pattern
The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
