127 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
FDA Recall
Terminated
·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHB·November 20, 2017
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code PHC·June 20, 2025
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code PHC·June 20, 2025
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
FDA Recall
Terminated
·Canon Medical System, USA, INC.·Product code MQB·April 18, 2018
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
FDA Recall
Terminated
·Brainlab AG Olof-Palme-Strasse 9 Munich Germany·Product code IYE·February 14, 2018
Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·January 14, 2016
Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on handheld computers.
FDA Recall
Terminated
·Cyberonics, Inc·Product code LYJ·July 24, 2009
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices.
FDA Recall
Terminated
·Canon Medical System, USA, INC.·Product code MQB·October 16, 2018
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·November 20, 2025
Lunar iDXA bone densitometer
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code KGI·December 3, 2019
Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code KGI·December 3, 2019
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code KGI·December 3, 2019
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.
FDA Recall
Terminated
·Physio Control, Inc.·Product code MKJ·February 8, 2013
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code KGI·December 3, 2019
MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
FDA Recall
Terminated
·Medtronic Inc.·January 31, 2017
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
FDA Recall
Terminated
·LABSTYLE INNOVATIONS 7, Derekh Menakhem Begin Ramat Gan Israel·Product code NBW·August 29, 2019
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
FDA Recall
Open, Classified
·Abbott Laboratories·Product code JJE·July 26, 2021