53 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
FDA Recall
Open, Classified
·Product code LRO·August 8, 2025
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SPPT-5F-7L/B SPPT-5F-7S SPPT-6F-10L SPPT-6F-10S SPPT-6F-10S SPPT-6F-12PL SPPT-6F-17PL SPPT-8F-10L SPPT-8F-12PL TAPS-100 TAPS-5F-10LT TAPS-5F-10T TAPS-5F-12PLT TAPS-5F-17PLT TAPS-5F-7LT TAPS-5F-7T TAPS-6F-10LT The Safety Paracentesis Procedure Tray is intended for drainage of fluid and specimen collection for diagnostic purposes or to remove excess fluid collections.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code PYC·June 11, 2024
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FGB·April 20, 2022
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·December 19, 2024
KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6, 43cm, NON STERILE, RxONLY, CE 0123
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·December 19, 2024
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
FDA Recall
Open, Classified
·Steris Corporation·Product code FEB·June 13, 2024
KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·December 19, 2024
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·March 25, 2026
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
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·May 26, 2023
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·December 19, 2024
Olympus OER-Pro
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FEB·October 31, 2025
Olympus OER-Mini
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FEB·October 31, 2025
Olympus OER-Elite
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FEB·October 31, 2025
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·March 25, 2026
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FGB·April 20, 2022
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEB·March 25, 2026
Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. Component: N/A
FDA Recall
Open, Classified
·Steris Corporation·Product code FEB·June 13, 2024