226 results
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34ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
FDA Recall
Open, Classified
·Stryker Communications·Product code FSY·February 23, 2026
Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.
FDA Recall
Open, Classified
·Stryker Communications·Product code FSY·March 22, 2019
Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.
FDA Recall
Open, Classified
·Stryker Communications·Product code FSY·March 22, 2019
Chromophare Surgical Light System , REF CH00000001
FDA Recall
Open, Classified
·Stryker Communications·Product code FSY·February 8, 2024
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
FDA Recall
Open, Classified
·Stryker Communications·Product code FSY·July 15, 2025
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD
FDA Recall
Open, Classified
·Stryker Communications·Product code FQO·January 29, 2021
EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.
FDA Recall
Open, Classified
·Stryker Communications·Product code FSY·November 13, 2018
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
FDA Recall
Open, Classified
·Stryker, Inc.·Product code DQO·December 6, 2023
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
FDA Recall
Open, Classified
·Stryker, Inc.·Product code QJP·December 6, 2023
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
FDA Recall
Open, Classified
·Stryker Sustainability Solutions·Product code JOW·April 14, 2023
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
FDA Recall
Open, Classified
·Stryker Sustainability Solutions·Product code NLH·May 10, 2024
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code DQY·August 9, 2022
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
FDA Recall
Open, Classified
·Stryker Neurovascular·Product code QJP·August 30, 2024
Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code DQY·July 27, 2023
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code DQY·July 27, 2023
Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code DQY·July 27, 2023
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code DQY·July 27, 2023
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code DQY·July 27, 2023
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code DQY·July 27, 2023
Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code DQY·July 27, 2023