26 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
FDA Recall
Open, Classified
·Elekta, Inc.·Product code IYE·May 5, 2023
Tenaculum, Plastic
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
FDA Recall
Terminated
·Instrumed International, Inc.·Product code HDC·September 8, 2014
IUD Insertion Pack
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
Foundation Kit
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
Standard IUD Insertion Kit
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, GYN Disposables,Inc. 2671 Appling Road, Memphis, TN 38133, ph 901.377.2200, fx 901.377.2207 Intended for intrauterine device (IUD) insertion.
FDA Recall
Terminated
·GYN Disposables Inc·Product code HDC·July 29, 2011
IUD Insertion Kit
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
Endometrial Biopsy Kit
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
FDA Recall
Open, Classified
·Hologic, Inc·Product code MUE·April 8, 2026
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D
FDA Recall
Open, Classified
·Hologic, Inc.·Product code OTE·January 16, 2023
ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·April 13, 2015
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·December 20, 2024
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Recall
Open, Classified
·Max Mobility LLC·Product code ITI·August 12, 2025
ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment.
FDA Recall
Terminated
·MDC Acquisition Co.·Product code FPS·April 23, 2010
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.
FDA Recall
Terminated
·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
FDA Recall
Terminated
·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
FDA Recall
Terminated
·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code LNZ·February 12, 2024
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code CAE·November 6, 2023