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.
- 2024-05-01FDA-DeviceHowmedica Osteonics Corp.Class IITRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- 2024-05-01FDA-DeviceSEASPINE ORTHOPEDICS CORPORATIONClass IIMariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
- 2024-05-01FDA-DeviceEBI, LLCClass II48" Lead Wires, Replacement Part Number: 1067724-4
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2024-05-01FDA-DeviceEBI, LLCClass II20" Lead Wires, Replacement Part Number: 1067724-2
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2024-05-01FDA-DeviceEBI, LLCClass IIBiomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2024-05-01FDA-DeviceEBI, LLCClass IIBiomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2024-05-01FDA-DeviceXENEX Disinfection Services Inc.Class IILightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.
Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.
- 2024-05-01FDA-DeviceROUTE 92 MEDICAL INCClass IRoute 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
- 2024-05-01FDA-DeviceROUTE 92 MEDICAL INCClass IRoute 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
- 2024-05-01FDA-DeviceROUTE 92 MEDICAL INCClass IRoute 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
- 2024-05-01FDA-DeviceROUTE 92 MEDICAL INCClass IRoute 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
- 2024-05-01FDA-DeviceROUTE 92 MEDICAL INCClass IRoute 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
- 2024-05-01FDA-DeviceZimmer, Inc.Class IINexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
- 2024-05-01FDA-DeviceBiomet, Inc.Class IIVanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
- 2024-05-01FDA-DeviceAlcon Research, LLCClass IIVarious Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials. Below are the various Alcon Customer Paks and Pak REF Numbers: 0515-66 ELMENDORF AFB CATARACT 3RD MED CTR 0752-74 CATARACT V A MED CTR 1119-82 DR DAVID B LEACH PALOUSE SURGERY CENT
Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
- 2024-05-01FDA-DeviceSEASPINE ORTHOPEDICS CORPORATIONClass IIMariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems.
Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
- 2024-05-01FDA-DeviceParker Laboratories, Inc.Class IIRedux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
Product demonstrates low viscosity.
- 2024-05-01FDA-DeviceIon Beam Applications S.A.Class IIIBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
- 2024-05-01FDA-DeviceAbbott Molecular, Inc.Class IIAlinity m System, Part Number: 08N53-002
The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.
- 2024-05-01FDA-DeviceSiemens Medical Solutions USA, Inc.Class IIACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
- 2024-05-01FDA-DeviceSiemens Medical Solutions USA, Inc.Class IIACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
- 2024-05-01FDA-DeviceSiemens Medical Solutions USA, Inc.Class IIACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
- 2024-05-01FDA-DeviceBiomerieux IncClass IVITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
- 2024-05-01FDA-DeviceLEICA BIOSYSTEMS NUSSLOCH GMBHClass IILeica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.
- 2024-04-24FDA-DeviceSiemens Medical Solutions USA, IncClass IISiemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355 Artis zee floor MN- 10094142 Artis zee biplane MN- 10094143
Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
- 2024-04-24FDA-DeviceSmith & Nephew Medical, Ltd.Class IIRENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
- 2024-04-24FDA-DeviceSmith & Nephew Medical, Ltd.Class IIRENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
- 2024-04-24FDA-DeviceRaye's Inc.Class IISW Bari Lift & Transfer, Model Number 38060000
Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.
- 2024-04-24FDA-DeviceRandox Laboratories Ltd.Class IIMicroalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
- 2024-04-24FDA-DeviceRandox Laboratories Ltd.Class IIMicroalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
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