20 results
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11ms
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Sources: EU EUDAMED, US FDA
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code LOD·November 7, 2022
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code LOD·November 7, 2022
OttLite Rechargeable UVC Disinfecting Wand
FDA Recall
Open, Classified
·Ottlite TEchnologies, Inc.·Product code RHP·November 17, 2022
Access 2 Immunoassay Analyzer, Catalog Number 81600N
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JJE·February 5, 2025
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
FDA Recall
Open, Classified
·Tandem Diabetes Care, Inc.·Product code QFG·March 5, 2024
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)
FDA Recall
Open, Classified
·Medical Depot Inc.·Product code ITJ·June 14, 2024
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)
FDA Recall
Open, Classified
·Medical Depot Inc.·Product code ITJ·June 14, 2024
11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·January 8, 2026
CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·July 7, 2022
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·November 14, 2025
11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·November 14, 2025
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·November 14, 2025
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FBO·September 25, 2023
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones. Component: ShockPulse Lithotripsy System
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·October 8, 2025
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code GKA·April 7, 2022