Cook Recalls
266 recalls on record · December 1, 1969 to December 29, 2021 · Medical Devices, Vehicles
Recalls by year
69
71
13
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15
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18
19
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21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, includin
Hazard: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
Hazard: Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.
November 27, 2019Medical DevicesFDA
Cook Inc. recalls Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Hazard: Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.
June 26, 2019Medical DevicesFDA
Cook Inc. recalls Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZI
Hazard: 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 the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.
June 26, 2019Medical DevicesFDA
Cook Inc. recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G3
Hazard: 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 procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.
June 26, 2019Medical DevicesFDA
Cook Inc. recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G352
Hazard: 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 procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.
June 26, 2019Medical DevicesFDA
Cook Inc. recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G352
Hazard: 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 procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.
June 19, 2019Medical DevicesFDA
Cook Inc. recalls Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Hazard: The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
June 12, 2019Medical DevicesFDA
Cook Inc. recalls Thoracentesis Set, RPN C-THS-850, Order # G03286
Hazard: Affected products may have been manufactured with the catheter distal end hole too small
June 12, 2019Medical DevicesFDA
Cook Inc. recalls Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
Hazard: Affected products may have been manufactured with the catheter distal end hole too small
June 12, 2019Medical DevicesFDA
Cook Inc. recalls Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
Hazard: Affected products may have been manufactured with the catheter distal end hole too small
June 12, 2019Medical DevicesFDA
Cook Inc. recalls Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Hazard: Affected products may have been manufactured with the catheter distal end hole too small
May 29, 2019Medical DevicesFDA
Cook Inc. recalls Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.
Hazard: Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.