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.
- 2024-03-13FDA-DeviceMicro Therapeutics, Inc.Class IIThe Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to incr
European version of microcatheter were distributed within US which contain a different "Indications for Use".
- 2024-03-13FDA-DeviceInvacare CorporationClass IIInvacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW
Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
- 2024-03-13FDA-DeviceCanon Medical System, USA, INC.Class IIVantage Titan, Model: MRT-1504
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- 2024-03-13FDA-DeviceCanon Medical System, USA, INC.Class IIMRI system: Vantage Elan, Model: MRT-2020
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- 2024-03-13FDA-DeviceCanon Medical System, USA, INC.Class IIMRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- 2024-03-13FDA-DeviceAesculap IncClass IIDISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
The sterile blister packaging may be damaged, and sterility may be compromised.
- 2024-03-13FDA-DeviceAesculap IncClass IIDISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
The sterile blister packaging may be damaged, and sterility may be compromised.
- 2024-03-13FDA-DeviceAesculap IncClass IIDISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
The sterile blister packaging may be damaged, and sterility may be compromised.
- 2024-03-13FDA-DeviceAesculap IncClass IIDISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
The sterile blister packaging may be damaged, and sterility may be compromised.
- 2024-03-13FDA-DeviceAesculap IncClass IIDISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
The sterile blister packaging may be damaged, and sterility may be compromised.
- 2024-03-13FDA-DeviceSynthes (USA) Products LLCClass IIOpal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Products not sterilized, sterility cannot be confirmed
- 2024-03-13FDA-DeviceSynthes (USA) Products LLCClass IIVA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
Products not sterilized, sterility cannot be confirmed
- 2024-03-13FDA-DeviceSynthes (USA) Products LLCClass IITFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
Products not sterilized, sterility cannot be confirmed
- 2024-03-13FDA-DeviceSynthes (USA) Products LLCClass IITFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
Products not sterilized, sterility cannot be confirmed
- 2024-03-13FDA-DeviceSynthes (USA) Products LLCClass IIRAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
Products not sterilized, sterility cannot be confirmed
- 2024-03-13FDA-DeviceSynthes (USA) Products LLCClass IIRIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary ca
Products not sterilized, sterility cannot be confirmed
- 2024-03-13FDA-DeviceSynthes (USA) Products LLCClass II2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
Products not sterilized, sterility cannot be confirmed
- 2024-03-13FDA-DeviceSynthes (USA) Products LLCClass II1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Products not sterilized, sterility cannot be confirmed
- 2024-03-13FDA-DeviceSynthes (USA) Products LLCClass II13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Products not sterilized, sterility cannot be confirmed
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS XT 7600 Integrated System, Catalog No. 6844461
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS XT 3400 Chemistry System, Catalog No. 6844458
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS XT 7600 Integrated System, Catalog No. 6844461
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS XT 3400 Chemistry System, Catalog No. 6844458
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- 2024-03-13FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- 2024-03-13FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.
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