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 8
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
These labels are deterministic app interpretations, not FDA categories.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
These labels are deterministic app interpretations, not FDA categories.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
These labels are deterministic app interpretations, not FDA categories.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Code information
Kit Lot #'s 2373868, 2397890, 2407867, 2410931, 2417878, 2417880
Distribution pattern
USA Nationwide Distribution
device · product 4 of 8
PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
These labels are deterministic app interpretations, not FDA categories.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Code information
Kit Lot #'s 2373869, 2375897, 2382870, 2397889, 2410932
Distribution pattern
USA Nationwide Distribution
device · product 5 of 8
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
These labels are deterministic app interpretations, not FDA categories.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Code information
Kit Lot #'s 2383867, 2397883
Distribution pattern
USA Nationwide Distribution
device · product 6 of 8
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
These labels are deterministic app interpretations, not FDA categories.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Code information
Kit Lot # 2410919
Distribution pattern
USA Nationwide Distribution
device · product 7 of 8
PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
These labels are deterministic app interpretations, not FDA categories.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Code information
Kit Lot #'s 2367883, 2383868, 2397882, 2410914
Distribution pattern
USA Nationwide Distribution
device · product 8 of 8
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
These labels are deterministic app interpretations, not FDA categories.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
