195 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Colonoscope, Model Number PCF-Q180AL.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·January 11, 2024
Colonoscope, Model Number CF-Q180AL.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·January 11, 2024
Colonoscope, Model Number PCF-H190TL.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·January 11, 2024
Colonoscope, Model Number CF-H180AL.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·January 11, 2024
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEI·June 21, 2024
Colonoscope, Model Number PCF-HQ190L.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·January 11, 2024
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·May 4, 2023
POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEI·March 7, 2024
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
FDA Recall
Open, Classified
·Envisiontec US Llc·Product code EBZ·January 20, 2022
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
FDA Recall
Open, Classified
·Sklar Instruments·Product code FBX·December 3, 2024
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
FDA Recall
Open, Classified
·Sklar Instruments·Product code JYG·December 3, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·November 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·November 25, 2024
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
FDA Recall
Open, Classified
·Genicon, Inc.·Product code N/A·August 25, 2020
POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0523CJDA
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEI·March 7, 2024
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
FDA Recall
Open, Classified
·Sklar Instruments·Product code FZS·December 3, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·November 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·November 25, 2024
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEI·September 4, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423810 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·November 25, 2024