🏥 Medical Devices • 15,809 recalls
Villa Radiology Systems
It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
Villa Radiology Systems
It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device.
Boston Scientific
Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expecte
Siemens Medical Solutions USA
Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.
Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
Ceterix Orthopedics
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Teleflex Medical
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.
Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.
The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
Interactive Motion Technologies
Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.
Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its Ready position prior to packaging.
ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.
The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.
ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.
Baxter Healthcare
Leakage from the inlet port of the 15L Cycler Drainage Bags.
ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received.
ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. No complaints were received.