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.
- 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.
- 2024-10-30FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
- 2024-10-30FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
- 2024-10-30FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAVIGATIONAL SPINE FUSION, REF DYNJ45153B; 7) FEET, ELBOW, AND ANKLE TEGH-LF, REF DYNJ46719B; 8) PLASTIC HAND PACK TEGH-LF, REF DYNJ46739B; 9) CVL INSERTION KIT-LF, REF DYNJ48587A; 10) CVL INSERTION KIT-LF, REF DYNJ
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
- 2024-10-30FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A; 8) CATARACT PACK WRO-LF, REF DYNJ41861; 9) EYE PACK, REF DYNJ43911; 10) PHACO PACK, REF DYNJ44748I; 11) DR DRUMMOND EYE PACK, REF DYNJ45344G; 12) OPHTHALMIC PACK, REF DYNJ47275A; 13
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
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