Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-07-15FDA-DeviceTomtec Imaging Systems GmbhClass IITOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.1
The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study.
- 2020-07-15FDA-DeviceMedtronic Perfusion SystemsClass IIExtra corporeal circuit with bio-active surface.
Affected products failed a sterilization test.
- 2020-07-15FDA-DeviceRadiometer Medical ApSClass IIBlood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.
Potential risk of patient mix-up on analyzers due to software issues.
- 2020-07-15FDA-DeviceRadiometer Medical ApSClass IIBlood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.
Potential risk of patient mix-up on analyzers due to software issues.
- 2020-07-15FDA-DeviceProdimed Plastimed DivisionClass IIProdimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
Lack of assurance of sterility
- 2020-07-15FDA-DeviceProdimed Plastimed DivisionClass IIProdimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
Lack of assurance of sterility
- 2020-07-15FDA-DeviceProdimed Plastimed DivisionClass IIProdimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
Lack of assurance of sterility
- 2020-07-15FDA-DeviceProdimed Plastimed DivisionClass IIProdimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
Lack of assurance of sterility
- 2020-07-15FDA-DeviceProdimed Plastimed DivisionClass IIProdimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
Lack of assurance of sterility
- 2020-07-15FDA-DeviceProdimed Plastimed DivisionClass IIProdimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
Lack of assurance of sterility
- 2020-07-15FDA-DeviceVerathon, Inc.Class IGlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to work with video endoscopes, in conjunction with ancillary equipment, for endoscopic procedures.
When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this force is transferred to the HDMI PCB, which may result in video synchronization interruption, loss of live image/blank screen, no cameras connected monitor warning, may present risk to patients, in which time to intubation is more critical.
- 2020-07-08FDA-DeviceEthicon, Inc.Class IIPERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
- 2020-07-08FDA-DeviceSmiths Medical ASD Inc.Class IIPediatric Adjustable Flange Tracheostomy Tube Cuffless
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
- 2020-07-08FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
- 2020-07-08FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
- 2020-07-08FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
- 2020-07-08FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
- 2020-07-08FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
- 2020-07-08FDA-DevicePreventice Services, LLCClass IIBodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.
The device data being collected and transferred to the monitoring center may not be accurate due to nonvalidated association between the phone software and the heart monitors, therefore, the patient's report should not be used to evaluate their condition.
- 2020-07-08FDA-DeviceOrtho Organizers, Inc.Class IIMaestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484
Orthodontic Bracket is mislabeled
- 2020-07-08FDA-DeviceOrtho Organizers, Inc.Class IIMaestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
Orthodontic Bracket is mislabeled
- 2020-07-08FDA-DeviceMueller Sports Medicine, IncClass IIMueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".
- 2020-07-08FDA-DeviceBaxter Healthcare CorporationClass IIFlow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
- 2020-07-08FDA-DeviceElekta, Inc.Class IIElekta Unity, Image-Guided Radiation Therapy System
There have been reports of excessive heating in the MRL Gradient Connection Module.
- 2020-07-08FDA-DeviceShanghai United Imaging Healthcare Co., Ltd.Class IIuCT 530 Computed Tomography X-Ray System
Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
- 2020-07-08FDA-DeviceFujifilm Medical Systems U.S.A., Inc.Class IIFujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis
- 2020-07-08FDA-DeviceSiemens Healthcare Diagnostics Inc.Class IISiemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard
- 2020-07-08FDA-DeviceSiemens Healthcare Diagnostics Inc.Class IISiemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard
- 2020-07-08FDA-DeviceRadiometer Medical ApSClass IIABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.
- 2020-07-08FDA-DeviceRadiometer Medical ApSClass IIABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.
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