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 5
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Code information
Lot LS20G3274I
Distribution pattern
Distribution in the following US states: CA, MA, and SC.
device · product 2 of 5
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Code information
Lot UR20F2702I
Distribution pattern
Distribution in the following US states: CA, MA, and SC.
device · product 3 of 5
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Code information
Lot LS20E2538I and 110320C
Distribution pattern
Distribution in the following US states: CA, MA, and SC.
device · product 4 of 5
SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002
