62 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
FDA Recall
Open, Classified
·Medartis AG Hochbergerstrasse 60e Basel Town Switzerland·Product code HWC·January 9, 2026
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
FDA Recall
Open, Classified
·Medartis AG Hochbergerstrasse 60e Basel Town Switzerland·Product code HWC·January 9, 2026
Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code JAK·October 14, 2011
Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·October 14, 2011
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).
FDA Recall
Terminated
·B Braun Medical Inc·Product code KDI·January 28, 2022
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).
FDA Recall
Terminated
·B Braun Medical Inc·Product code KDI·January 28, 2022
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code CAH·August 29, 2022
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code CAH·August 29, 2022
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code CAH·August 29, 2022
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code CAH·August 29, 2022
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code CAH·August 29, 2022
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code CAH·August 29, 2022
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Recall
Terminated
·Oscor, Inc.·Product code DYB·October 5, 2016
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Recall
Terminated
·Oscor, Inc.·Product code DYB·October 5, 2016
OSCOR ADELANTE BREEZEWAY 10F C55 S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Recall
Terminated
·Oscor, Inc.·Product code DYB·October 5, 2016
OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Recall
Terminated
·Oscor, Inc.·Product code DYB·October 5, 2016
OSCOR ADELANTE BREEZEWAY 8F C55 S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Recall
Terminated
·Oscor, Inc.·Product code DYB·October 5, 2016
OSCOR ADELANTE BREEZEWAY 8F C120 S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Recall
Terminated
·Oscor, Inc.·Product code DYB·October 5, 2016
OSCOR ADELANTE BREEZEWAY 8F C70 S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Recall
Terminated
·Oscor, Inc.·Product code DYB·October 5, 2016
OSCOR ADELANTE BREEZEWAY 8F C55 S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Recall
Terminated
·Oscor, Inc.·Product code DYB·October 5, 2016