140 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Dimension Vista Assays: Enzymatic Creatine (ECRE)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JFY·March 17, 2016
EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·March 22, 2013
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·May 11, 2015
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·May 11, 2015
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·March 28, 2013
Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
FDA Recall
Terminated
·Dade Behring, Inc.·Product code JFY·September 29, 2008
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60C} semi-critical endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·September 27, 2016
EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·February 13, 2008
EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·February 13, 2008
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code EOQ·April 1, 2022
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FAJ·April 1, 2022
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
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
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code EOB·April 1, 2022
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
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·April 1, 2022
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
11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·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
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSUE 11278VSUEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·April 1, 2022