Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-08-04FDA-DeviceCooperVision Inc.Class IIFRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceCooperVision Inc.Class IIAQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceCooperVision Inc.Class IICLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceRemel IncClass IIThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Out of Specification
- 2021-08-04FDA-DeviceSouthmedic, Inc.Class IIOxyMask O2 Adult REF OM-1125-14
Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.
- 2021-08-04FDA-DeviceMaquet Medical Systems USAClass IIHeater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
- 2021-08-04FDA-DeviceGE Healthcare, LLCClass IICARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
- 2021-08-04FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; RayStation 10.0 (10.0.0.1154) 07350002010303; RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365; RayStation 10.1 (10.1.0.613) 07350002010310; RayStation 11.0 (11.0.0.951) 0735000201
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
- 2021-08-04FDA-DeviceB. Braun Medical, Inc.Class IIInfusomat Space Volumetric Pump Administration Set, Product Code 490100
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
- 2021-08-04FDA-DeviceMedtronic Vascular, Inc.Class IIMedtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
- 2021-08-04FDA-DeviceMedtronic Vascular, Inc.Class IIEndurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
- 2021-08-04FDA-DeviceCytocell Ltd.Class IICytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
- 2021-08-04FDA-DeviceEight Medical International BVClass IRecirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 36mm, Novation GXL Liner, 10 Deg Face, 36mm. (note: inadvertently left out of original posting) Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalo
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized, 36mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0, 22mm ID. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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