Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-12-13FDA-DeviceIntegra LifeSciences Corp.Class IIIntegra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
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
- 2023-12-13FDA-DeviceIntegra LifeSciences Corp.Class IIIntegra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
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
- 2023-12-13FDA-DeviceStanbio Laboratory, LPClass IISTAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
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.
- 2023-12-13FDA-DeviceVyaire MedicalClass IIvyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
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.
- 2023-12-13FDA-DeviceVyaire MedicalClass IIvyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
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.
- 2023-12-13FDA-DeviceRemington Medical, Inc.Class IIRemington MEDICAL Drainage Bag, REF 600-D;
There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
- 2023-12-13FDA-DeviceAtrium Medical CorporationClass IIAtrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
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.
- 2023-12-13FDA-DeviceAtrium Medical CorporationClass IIAtrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
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.
- 2023-12-13FDA-DeviceAtrium Medical CorporationClass IIAtrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
- 2023-12-13FDA-DeviceHeartware, Inc.Class IIPUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
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
- 2023-12-13FDA-DeviceHeartware, Inc.Class IIHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
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
- 2023-12-13FDA-DeviceHeartware, Inc.Class IIPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
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
- 2023-12-13FDA-DeviceHeartware, Inc.Class II1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
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
- 2023-12-13FDA-DeviceHeartware, Inc.Class IIPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
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
- 2023-12-13FDA-DeviceHeartware, Inc.Class IIPUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
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
- 2023-12-13FDA-DeviceHeartware, Inc.Class IIHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
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
- 2023-12-13FDA-DeviceHeartware, Inc.Class IISTERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
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
- 2023-12-13FDA-DeviceHeartware, Inc.Class IIHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
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
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceStaar Surgical CompanyClass IIEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-13FDA-DeviceWilson-Cook Medical Inc.Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
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.
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