Medical DeviceJun 26, 2019
GE Healthcare Discovery PET/CT 710 Product Usage: The systems are intended for head and recall — FDA Z-1746-2019
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Class IIFDA: OngoingGE Healthcare, LLC
Latest records
Latest recalls — page 1223
The newest recall records with useful source details are listed here.
Medical DeviceJun 26, 2019
Cook Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog recall — FDA Z-1757-2019
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the…
Class IFDA: TerminatedCook Inc.
Medical DeviceJun 26, 2019
Teleflex Medical Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) recall — FDA Z-1762-2019
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan…
Class IFDA: TerminatedTeleflex Medical
Medical DeviceJun 26, 2019
Cook Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog recall — FDA Z-1756-2019
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the…
Class IFDA: TerminatedCook Inc.
Medical DeviceJun 26, 2019
Cook Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog recall — FDA Z-1758-2019
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the…
Class IFDA: TerminatedCook Inc.
Medical DeviceJun 26, 2019
Teleflex Medical Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm recall — FDA Z-1766-2019
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan…
Class IFDA: TerminatedTeleflex Medical
Medical DeviceJun 26, 2019
Cook Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108 recall — FDA Z-1844-2019
may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in…
Class IIFDA: TerminatedCook Inc.
Medical DeviceJun 26, 2019
Covidien EGIA45 CT AR MD THK REL, EGIA45CTAMT recall — FDA Z-1831-2019
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
Class IIFDA: OngoingCovidien LLC
Medical DeviceJun 26, 2019
Cytocell Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 recall — FDA Z-1843-2019
There is an error in the chromomap on the package insert.
Class IIIFDA: TerminatedCytocell Ltd.
Medical DeviceJun 26, 2019
Ethicon ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product recall — FDA Z-1842-2019
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Class IIFDA: TerminatedEthicon, Inc.
Medical DeviceJun 26, 2019
Covidien EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT recall — FDA Z-1829-2019
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
Class IIFDA: OngoingCovidien LLC
Medical DeviceJun 26, 2019
GE Healthcare Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and recall — FDA Z-1747-2019
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 26, 2019
GE Healthcare Discovery PET/CT 610 Product Usage: The systems are intended for head and recall — FDA Z-1745-2019
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 26, 2019
GE Healthcare LVivo EF app on Vscan Extend recall — FDA Z-1839-2019
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 26, 2019
Covidien SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT recall — FDA Z-1833-2019
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
Class IIFDA: OngoingCovidien LLC
Medical DeviceJun 26, 2019
Teleflex Medical Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal recall — FDA Z-1759-2019
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan…
Class IFDA: TerminatedTeleflex Medical
Medical DeviceJun 26, 2019
Teleflex Medical Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal recall — FDA Z-1765-2019
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan…
Class IFDA: TerminatedTeleflex Medical
Medical DeviceJun 26, 2019
Covidien SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT recall — FDA Z-1836-2019
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
Class IIFDA: OngoingCovidien LLC
Medical DeviceJun 26, 2019
Covidien EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT recall — FDA Z-1828-2019
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
Class IIFDA: OngoingCovidien LLC
Medical DeviceJun 26, 2019
Covidien EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT recall — FDA Z-1830-2019
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
Class IIFDA: OngoingCovidien LLC
Medical DeviceJun 26, 2019
Covidien SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT recall — FDA Z-1834-2019
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
Class IIFDA: OngoingCovidien LLC
Medical DeviceJun 26, 2019
Covidien EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT recall — FDA Z-1825-2019
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak,…
Class IIFDA: OngoingCovidien LLC
Medical DeviceJun 26, 2019
GE Healthcare Discovery Ml Product Usage: The systems are intended for head and whole body recall — FDA Z-1749-2019
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJun 26, 2019
Ethicon ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product recall — FDA Z-1841-2019
Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
Class IIFDA: TerminatedEthicon, Inc.
Browse by month
Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026182 records · 4 categoriesSeptember 2026363 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories