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
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
These labels are deterministic app interpretations, not FDA categories.
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Code information
Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447
Distribution pattern
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
device · product 2 of 2
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
These labels are deterministic app interpretations, not FDA categories.
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Code information
Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657
Distribution pattern
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
