GE Medical Systems, LLC - Vivid S5 - Class 2 Recall
Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - Vivid i - Class 2 Recall
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON Juniper Diagnostic Ultrasound System - Class 2 Recall
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 12, 2022 Category: Medical Devices Source Type: alerts
MED NAP OBSTETRICAL TOWELETTE (benzalkonium chloride) liquid [Acme United Corporation]
Updated Date: Wed, 02 Mar 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 2, 2022 Category: Drugs & Pharmacology Source Type: alerts
GYNAZOLE 1 (butoconazole nitrate) cream [Padagis Israel Pharmaceuticals Ltd]
Updated Date: Mon, 13 Dec 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 13, 2021 Category: Drugs & Pharmacology Source Type: alerts
OBSTETRICAL TOWELETTE (benzalkonium chloride) cloth [Jianerkang Medical Co., Ltd]
Updated Date: Mon, 02 Aug 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 2, 2021 Category: Drugs & Pharmacology Source Type: alerts
GYNAZOLE 1 (butoconazole nitrate) cream [Perrigo New York Inc]
Updated Date: Wed, 03 Feb 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 3, 2021 Category: Drugs & Pharmacology Source Type: alerts
ROi CPS LLC - Regard - Class 2 Recall
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2020 Category: Medical Devices Source Type: alerts
Philips Ultrasound Inc - Philips EPIQ and Affiniti Ultrasound Systems - Class 2 Recall
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperat...
Source: Medical Device Recalls - August 7, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - AURIGA 30 GENERAL ZERO COST SYSTEM - Class 2 Recall
AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - AURIGA XL 4007 GENERAL ZEROCOST SYSTE - Class 2 Recall
AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - AURIGA 30 GENERAL DEMO SYSTEM - Class 2 Recall
AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - AURIGA XL 4007 GENERAL SYSTEM - Class 2 Recall
AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - AURIGA XL 4007 GENERAL DEMO SYSTEM - Class 2 Recall
AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - AURIGA 30 BRAZIL ZERO COST SYSTEM - Class 2 Recall
AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
