Medical device recalls
39048 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-10-30FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Operating Table TruSystem 7000, Product code REF 1841046
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- 2024-10-30FDA-DeviceBlue OrthoClass IIPredict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Predict+ is being recalled for lack of pre-market clearance/approval.
- 2024-10-30FDA-DeviceDiasol, IncClass IIDiasol Acid Concentrate REF G100325-10Dex 100
Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.
- 2024-10-30FDA-DeviceMedtronic NeuromodulationClass IIMedtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IIsmiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar Disposable Transducer 1/EA, Product Code REF MX950
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex Arterial Kit 1/EA, Product Code REF MX7827
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar Single ICP Set 1/EA, Product Code REF MX20897
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief