February 7, 2024Medical DevicesFDA
Vortex Surgical Inc. recalls Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Hazard: Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.
February 7, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
Hazard: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
February 7, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
Hazard: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
February 7, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
Hazard: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
February 7, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
Hazard: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
February 7, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
Hazard: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
February 7, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Hazard: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
February 7, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
Hazard: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
February 7, 2024Medical DevicesFDA
Philips North America recalls SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls Achieva XR. Model (REF) Numbers 781153, 781253.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls Achieva 1.5T Initial system. Model (REF) Numbers 781178.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Philips North America recalls Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Hazard: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adul
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adult
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adult
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in a
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults a
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults a
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.