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
Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
Code information
1) DYNJAA254A, UDI-DI 10195327686260 (each) 40195327686261 (case), Lot Number 24KBR956, 24LBA655; 2) DYNJAA262A, UDI-DI 10195327208172 (each) 40195327208173 (case), Lot Number 24LBD397
Distribution pattern
US States: CA, NY
device · product 2 of 2
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
Code information
1) ACC010809, UDI-DI 10198459012235 (each) 40198459012236 (case), Lot Number 24JDC400; 2) ACC010813, UDI-DI 10198459012556 (each) 40198459012557 (case), Lot Number 24KDA437
