Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-11-24FDA-DeviceCordis CorporationClass IISMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
- 2021-11-24FDA-DeviceCordis CorporationClass IISMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
- 2021-11-24FDA-DeviceCordis CorporationClass IISMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
- 2021-11-17FDA-DeviceBaxter Healthcare CorporationClass IIHemodialysis Delivery System, Software Version 2.x.
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
- 2021-11-17FDA-DeviceBioCheck, Inc.Class IIT4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
- 2021-11-17FDA-DevicePhilips North America LlcClass IIPhilips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.
- 2021-11-17FDA-DeviceTherakos, Inc.Class IITHERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
- 2021-11-17FDA-DeviceZ-Medica, LLCClass IIQuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Lack of Packaging seal integrity may result in a sterile barrier breach.
- 2021-11-17FDA-DeviceCovidien LlcClass IICovidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.
- 2021-11-17FDA-DeviceZhejiang Kindly Medical Devices Co., Ltd.Class IIHENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
Potential for difficulty in safety mechanism activation.
- 2021-11-17FDA-DeviceZhejiang Kindly Medical Devices Co., Ltd.Class IIHENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
Potential for difficulty in safety mechanism activation.
- 2021-11-17FDA-DeviceZhejiang Kindly Medical Devices Co., Ltd.Class IIMcKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS
Potential for difficulty in safety mechanism activation.
- 2021-11-17FDA-DeviceZhejiang Kindly Medical Devices Co., Ltd.Class IIMcKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS
Potential for difficulty in safety mechanism activation.
- 2021-11-17FDA-DeviceZhejiang Kindly Medical Devices Co., Ltd.Class IIMcKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS
Potential for difficulty in safety mechanism activation.
- 2021-11-17FDA-DeviceZhejiang Kindly Medical Devices Co., Ltd.Class IIMcKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Potential for difficulty in safety mechanism activation.
- 2021-11-17FDA-DeviceELLUME LTDClass IEllume COVID-19 Home Test
Due to a higher rate of false positive test results.
- 2021-11-10FDA-DeviceJjgc Industria E Comercio De Materials Dentarios SaClass IIGM Helix Acqua Implant 3.5x10, Article No. 140.944
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
- 2021-11-10FDA-DeviceMICROVENTION INC.Class IIAspiration Syringe Kit, REF: MVSK60
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
- 2021-11-10FDA-DeviceMedtronic NeuromodulationClass IIClinician Programmer Application (CPA) model A610 Clinician Software Application
A software anomaly may occur with the clinician programmer application.
- 2021-11-10FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815
Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient
- 2021-11-10FDA-DeviceBayer Medical Care, Inc.Class IIThe MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
- 2021-11-10FDA-DeviceImplant Direct Sybron Manufacturing LLCClass IIImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Packaged dental implant contains a different size then the size declared on the labeling.
- 2021-11-10FDA-DeviceImplant Direct Sybron Manufacturing LLCClass IIImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Packaged dental implant contains a different size then the size declared on the labeling.
- 2021-11-10FDA-DeviceSiemens Healthcare Diagnostics, IncClass IIADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
- 2021-11-10FDA-DeviceSiemens Healthcare Diagnostics, IncClass IIAtellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
- 2021-11-10FDA-DeviceLumenis, Inc.Class IIPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
- 2021-11-10FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.
- 2021-11-10FDA-DeviceFujiFilm Healthcare Americas CorporationClass IIArietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual
- 2021-11-10FDA-DeviceFujiFilm Healthcare Americas CorporationClass IILisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
- 2021-11-10FDA-DeviceFujiFilm Healthcare Americas CorporationClass IIArietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
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