December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ve
Hazard: Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
December 13, 2023Medical DevicesFDA
Stanbio Laboratory, LP recalls STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Hazard: Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.
December 13, 2023Medical DevicesFDA
Vyaire Medical recalls vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ven
Hazard: Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.
December 13, 2023Medical DevicesFDA
Vyaire Medical recalls vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ven
Hazard: Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.
December 13, 2023Medical DevicesFDA
Remington Medical, Inc. recalls Remington MEDICAL Drainage Bag, REF 600-D;
Hazard: There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
December 13, 2023Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Hazard: Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
December 13, 2023Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION
Hazard: Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
December 13, 2023Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Hazard: A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
December 13, 2023Medical DevicesFDA
Heartware, Inc. recalls PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Hazard: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
December 13, 2023Medical DevicesFDA
Heartware, Inc. recalls HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Hazard: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
December 13, 2023Medical DevicesFDA
Heartware, Inc. recalls PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Hazard: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
December 13, 2023Medical DevicesFDA
Heartware, Inc. recalls 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Hazard: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
December 13, 2023Medical DevicesFDA
Heartware, Inc. recalls PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Hazard: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
December 13, 2023Medical DevicesFDA
Heartware, Inc. recalls PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Hazard: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
December 13, 2023Medical DevicesFDA
Heartware, Inc. recalls HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
Hazard: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
December 13, 2023Medical DevicesFDA
Heartware, Inc. recalls STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
Hazard: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
December 13, 2023Medical DevicesFDA
Heartware, Inc. recalls HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Hazard: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Hazard: Their is a potential that intraocular implant devices may not meet specifications.
December 13, 2023Medical DevicesFDA
Wilson-Cook Medical Inc. recalls QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Hazard: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
December 13, 2023Medical DevicesFDA
Wilson-Cook Medical Inc. recalls QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
Hazard: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.