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Olympus Corporation of the Americas

317 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) recall (Z-1385-2024)Olympus Corporation of the Americas2024-03-27
Insufflation unit, UHI-4. recall (Z-1375-2024)Olympus Corporation of the Americas2024-03-25
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during recall (Z-1368-2024)Olympus Corporation of the Americas2024-03-22
Colonoscope, Model Number CF-H180AL. recall (Z-1205-2024)Olympus Corporation of the Americas2024-02-29
Colonoscope, Model Number CF-HQ190I. recall (Z-1206-2024)Olympus Corporation of the Americas2024-02-29
Colonoscope, Model Number CF-HQ190L. recall (Z-1207-2024)Olympus Corporation of the Americas2024-02-29
Colonoscope, Model Number CF-Q180AL. recall (Z-1208-2024)Olympus Corporation of the Americas2024-02-29
Colonoscope, Model Number PCF-H180AL. recall (Z-1209-2024)Olympus Corporation of the Americas2024-02-29
Colonoscope, Model Number PCF-H190DL. recall (Z-1210-2024)Olympus Corporation of the Americas2024-02-29
Colonoscope, Model Number PCF-H190L. recall (Z-1211-2024)Olympus Corporation of the Americas2024-02-29
Colonoscope, Model Number PCF-H190TL. recall (Z-1212-2024)Olympus Corporation of the Americas2024-02-29
Colonoscope, Model Number PCF-HQ190L. recall (Z-1213-2024)Olympus Corporation of the Americas2024-02-29
Colonoscope, Model Number PCF-Q180AL. recall (Z-1214-2024)Olympus Corporation of the Americas2024-02-29
ESG PK CUTTING FORCEPS, 5MM, 33CM recall (Z-1167-2024)Olympus Corporation of the Americas2024-02-20
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- de recall (Z-1071-2024)Olympus Corporation of the Americas2024-02-09
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle recall (Z-1004-2024)Olympus Corporation of the Americas2024-02-07
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympu recall (Z-1009-2024)Olympus Corporation of the Americas2024-02-07
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the recall (Z-0933-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures recall (Z-0934-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of t recall (Z-0935-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of stricture recall (Z-0936-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of t recall (Z-0937-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of t recall (Z-0938-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the recall (Z-0939-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures recall (Z-0940-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in recall (Z-0941-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictur recall (Z-0942-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in recall (Z-0943-2024)Olympus Corporation of the Americas2024-01-31
EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in recall (Z-0944-2024)Olympus Corporation of the Americas2024-01-31
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL- recall (Z-0748-2024)Olympus Corporation of the Americas2024-01-18
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, recall (Z-0716-2024)Olympus Corporation of the Americas2024-01-12
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC recall (Z-0717-2024)Olympus Corporation of the Americas2024-01-12
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS recall (Z-0718-2024)Olympus Corporation of the Americas2024-01-12
Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a vi recall (Z-0697-2024)Olympus Corporation of the Americas2024-01-10
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with recall (Z-0644-2024)Olympus Corporation of the Americas2024-01-05
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with recall (Z-0645-2024)Olympus Corporation of the Americas2024-01-05
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA recall (Z-0568-2024)Olympus Corporation of the Americas2023-12-15
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP recall (Z-0557-2024)Olympus Corporation of the Americas2023-12-14
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS recall (Z-0189-2024)Olympus Corporation of the Americas2023-11-09
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC recall (Z-0190-2024)Olympus Corporation of the Americas2023-11-09
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180 recall (Z-0191-2024)Olympus Corporation of the Americas2023-11-09
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDE recall (Z-0192-2024)Olympus Corporation of the Americas2023-11-09
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190 recall (Z-0193-2024)Olympus Corporation of the Americas2023-11-09
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 recall (Z-0194-2024)Olympus Corporation of the Americas2023-11-09
EVIS EXERA III Gastrointestinal Videoscope recall (Z-0288-2024)Olympus Corporation of the Americas2023-11-09
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. recall (Z-0075-2024)Olympus Corporation of the Americas2023-10-18
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, recall (Z-0108-2024)Olympus Corporation of the Americas2023-10-12
THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, l recall (Z-0109-2024)Olympus Corporation of the Americas2023-10-12
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 2 recall (Z-2659-2023)Olympus Corporation of the Americas2023-09-29
Veran Endobronchial: Models: INS-5925 SPiN Access Catheter 180 Degree for use w/ Pentax Sc recall (Z-2660-2023)Olympus Corporation of the Americas2023-09-29
Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (incl recall (Z-2661-2023)Olympus Corporation of the Americas2023-09-29
Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend 21ga, 1.8 OD recall (Z-2662-2023)Olympus Corporation of the Americas2023-09-29
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, recall (Z-2663-2023)Olympus Corporation of the Americas2023-09-29
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, recall (Z-2664-2023)Olympus Corporation of the Americas2023-09-29
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF- recall (Z-2490-2023)Olympus Corporation of the Americas2023-08-31
Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60. recall (Z-2491-2023)Olympus Corporation of the Americas2023-08-31
Olympus Bronchovideoscope, Model BF-Q180-AC recall (Z-2492-2023)Olympus Corporation of the Americas2023-08-31
Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180. recall (Z-2493-2023)Olympus Corporation of the Americas2023-08-31
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F. recall (Z-2494-2023)Olympus Corporation of the Americas2023-08-31
Olympus Airway Mobilescope, Models MAF-GM & MAF-TM. recall (Z-2495-2023)Olympus Corporation of the Americas2023-08-31
Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190. recall (Z-2496-2023)Olympus Corporation of the Americas2023-08-31
Olympus Bronchovideoscope, Models BF-MP190F. recall (Z-2497-2023)Olympus Corporation of the Americas2023-08-31
Olympus Bronchovideoscope, Models BF-XT190. recall (Z-2498-2023)Olympus Corporation of the Americas2023-08-31
Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2. recall (Z-2499-2023)Olympus Corporation of the Americas2023-08-31
Olympus Bronchovideoscope, Models BF-P190 & BF-XP190. recall (Z-2500-2023)Olympus Corporation of the Americas2023-08-31
Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V. recall (Z-2501-2023)Olympus Corporation of the Americas2023-08-31
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20. recall (Z-2502-2023)Olympus Corporation of the Americas2023-08-31
Olympus Bronchovideoscope, Models BF-3C160. recall (Z-2503-2023)Olympus Corporation of the Americas2023-08-31
Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP. recall (Z-2504-2023)Olympus Corporation of the Americas2023-08-31
Visera Hysterovideoscope Olympus HYF Type V recall (Z-2480-2023)Olympus Corporation of the Americas2023-08-29
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V recall (Z-2467-2023)Olympus Corporation of the Americas2023-08-28
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBER recall (Z-2447-2023)Olympus Corporation of the Americas2023-08-23
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for en recall (Z-2413-2023)Olympus Corporation of the Americas2023-08-17
UroPass Ureteral Access Sheaths, 5 pieces/box recall (Z-2401-2023)Olympus Corporation of the Americas2023-08-14
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which inclu recall (Z-2340-2023)Olympus Corporation of the Americas2023-08-04
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, docu recall (Z-2341-2023)Olympus Corporation of the Americas2023-08-04
Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of h recall (Z-2342-2023)Olympus Corporation of the Americas2023-08-04
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of recall (Z-2343-2023)Olympus Corporation of the Americas2023-08-04
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of recall (Z-2344-2023)Olympus Corporation of the Americas2023-08-04
Always-On Tip Tracked Instruments (SPiN Drive instruments) Brush, 15mm L, 1.8mm OD Intende recall (Z-2262-2023)Olympus Corporation of the Americas2023-07-28
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-In recall (Z-2263-2023)Olympus Corporation of the Americas2023-07-28
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup recall (Z-2264-2023)Olympus Corporation of the Americas2023-07-28
Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12m recall (Z-2265-2023)Olympus Corporation of the Americas2023-07-28
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm recall (Z-2266-2023)Olympus Corporation of the Americas2023-07-28
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1. recall (Z-2267-2023)Olympus Corporation of the Americas2023-07-28
Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, recall (Z-2268-2023)Olympus Corporation of the Americas2023-07-28
Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Inten recall (Z-2269-2023)Olympus Corporation of the Americas2023-07-28
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60 recall (Z-2011-2023)Olympus Corporation of the Americas2023-07-17
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 recall (Z-2012-2023)Olympus Corporation of the Americas2023-07-17
Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150 recall (Z-2013-2023)Olympus Corporation of the Americas2023-07-17
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 recall (Z-2014-2023)Olympus Corporation of the Americas2023-07-17
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170 recall (Z-2015-2023)Olympus Corporation of the Americas2023-07-17
Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-A recall (Z-2016-2023)Olympus Corporation of the Americas2023-07-17
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190 recall (Z-2017-2023)Olympus Corporation of the Americas2023-07-17
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal c recall (Z-1987-2023)Olympus Corporation of the Americas2023-06-21
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal cli recall (Z-1988-2023)Olympus Corporation of the Americas2023-06-21
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal c recall (Z-1989-2023)Olympus Corporation of the Americas2023-06-21
Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal cli recall (Z-1990-2023)Olympus Corporation of the Americas2023-06-21
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovide recall (Z-1613-2023)Olympus Corporation of the Americas2023-05-19
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ul recall (Z-1615-2023)Olympus Corporation of the Americas2023-05-19
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Every clearance here is in the API, with alerts when new ones post.