1,624 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
FDA Recall
Open, Classified
·Medtronic Neurosurgery·Product code JXG·December 8, 2020
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
FDA Recall
Open, Classified
·Medtronic Neurosurgery·Product code JXG·December 8, 2020
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code EOB·April 3, 2024
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
FDA Recall
Open, Classified
·Medtronic Neurosurgery·Product code JXG·December 8, 2020
Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code CAL·July 27, 2020
Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code CAL·July 27, 2020
Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code CAL·July 27, 2020
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.
FDA Recall
Open, Classified
·NxStage MDS Corporation·Product code KDI·January 29, 2024
Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code CAL·July 27, 2020
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
FDA Recall
Open, Classified
·Cardinal Health·Product code FCM·November 1, 2022
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
FDA Recall
Open, Classified
·Daavlin Distributing Company·Product code FTC·December 10, 2025
Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code CAL·July 27, 2020
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.
FDA Recall
Open, Classified
·Cardinal Health·Product code FCM·November 1, 2022
Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code CAL·July 27, 2020
Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code CAL·July 27, 2020
Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code CAL·July 27, 2020
Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.
FDA Recall
Open, Classified
·Stryker Corporation·Product code KDD·September 13, 2023
BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.
FDA Recall
Open, Classified
·RONAN MEDICAL LLC·Product code HCC·December 11, 2023
Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.
FDA Recall
Open, Classified
·AMEDA, INC.·Product code HGX·July 10, 2017
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
FDA Recall
Open, Classified
·Xcision Medical Systems, LLC·Product code IWB·November 30, 2023