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
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8) DCHN-22-20.0 G00013 9) DCHN-22-20.0-U G04338
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
device · product 2 of 8
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Code information
UDI: (01)00827002013773(17) Lot Number: 15786588
Distribution pattern
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
device · product 3 of 8
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Code information
UDI: (01)00827002094901(17) Lot Number: 15787864, 15804398
Distribution pattern
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
device · product 4 of 8
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
device · product 5 of 8
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Code information
UDI-DI: (01)00827002355620(17) Lot Number: 15791906
Distribution pattern
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
device · product 6 of 8
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38-15 6) JCD8.0-38-20
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Code information
1)JCD10.0-38-20 (01)00827002009936(17) Lot Numbers: 15794371, 15794373, 15794374, 15806068, 15816198, 15816199 15816200 2) JCD20.0-38-20 (01)00827002014718(17) Lot Numbers: 15784153, 15784159, 15784160, 15794192, 15794199, 15794202. 15804028 3) JCD22.0-38-20 (01)00827002014725(17) Lot Numbers: 15794207, 15806062 4) JCD6.0-38-15 (01)00827002009448(17) Lot Number: 15814407 5) JCD8.0-38-15 (01)00827002009998(17) Lot Numbers: 15797971, 15797979 6) JCD8.0-38-20 (01)00827002009806(17) Lot Number:15791073
Distribution pattern
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
device · product 7 of 8
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
device · product 8 of 8
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20- COONS G03928 2) JCD12.0-38-20- COONS G03929 3) JCD14.0-38-20- COONS G03932 4) JCD16.0-38-20- COONS G03947 5) JCD18.0-38-20- COONS G04051 6) JCD20.0-38-20- COONS G04264 7) JCD22.0-38-20- COONS G04443 8) JCD6.0-38-20- COONS G04221 9) JCD8.0-38-20- COONS G03927
