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
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509011
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
These labels are deterministic app interpretations, not FDA categories.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Worldwide distribution - US Nationwide and the country of Japan.
device · product 2 of 5
EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509051
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
These labels are deterministic app interpretations, not FDA categories.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Code information
GTIN: 08714729880493 Lot Numbers: 32162452, 32370861, 32714500
Distribution pattern
Worldwide distribution - US Nationwide and the country of Japan.
device · product 3 of 5
EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00566471
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
These labels are deterministic app interpretations, not FDA categories.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Worldwide distribution - US Nationwide and the country of Japan.
device · product 4 of 5
EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00568211
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
These labels are deterministic app interpretations, not FDA categories.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Code information
GTIN: 08714729285205 Lot Numbers: 32151880, 32247311, 32810232
Distribution pattern
Worldwide distribution - US Nationwide and the country of Japan.
device · product 5 of 5
EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509191
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
These labels are deterministic app interpretations, not FDA categories.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Code information
GTIN: 08714729880691 Lot Numbers: 32234291
Distribution pattern
Worldwide distribution - US Nationwide and the country of Japan.
