Recall Register

Olympus Corporation of the Americas: FDA recalls

FDA enforcement reports name Olympus Corporation of the Americas as the recalling firm in 141 events. The events have 415 product records. The recalls started from 2015 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

141 events, newest first.

FDA enforcement events of Olympus Corporation of the Americas
InitiatedProduct (first record)TypeClassRecordsStatus
18 Aug 2026POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessoriesDeviceClass II1Ongoing
7 Jul 2026Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.DeviceClass II1Ongoing
16 Jun 2026Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4DeviceClass II1Ongoing
5 Jun 2026Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigidDeviceClass II1Ongoing
5 May 2026Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.DeviceClass II4Ongoing
25 Mar 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.DeviceClass II12Ongoing
23 Mar 2026Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.DeviceClass II4Ongoing
27 Feb 2026Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis,…DeviceClass II2Ongoing
25 Feb 2026Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under…DeviceClass II7Ongoing
12 Feb 2026Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.DeviceClass II4Ongoing
29 Jan 2026Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.DeviceClass II2Ongoing
16 Jan 2026Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.DeviceClass I3Ongoing
8 Jan 2026Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic…DeviceClass II1Ongoing
7 Jan 2026Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.DeviceClass II30Ongoing
14 Nov 2025Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer…DeviceClass II3Ongoing
11 Nov 2025Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.DeviceClass II20Ongoing
30 Oct 2025Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.DeviceClass I1Ongoing
22 Oct 2025Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type SDeviceClass II12Ongoing
17 Oct 2025Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a…DeviceClass II1Ongoing
14 Oct 2025Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other…DeviceClass II1Ongoing
8 Oct 2025Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that…DeviceClass II1Ongoing
6 Oct 2025Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps,…DeviceClass II2Ongoing
11 Sep 2025BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150DeviceClass I23Ongoing
6 Aug 2025ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.DeviceClass I1Ongoing
25 Jul 2025Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments…DeviceClass II2Ongoing
18 Jun 2025Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.DeviceClass II8Ongoing
6 May 2025Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue…DeviceClass II4Ongoing
5 May 2025Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190VDeviceClass II1Ongoing
4 Apr 2025Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component:…DeviceClass II1Ongoing
15 Jan 2025Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number:…DeviceClass I1Ongoing
18 Dec 2024Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.DeviceClass I1Ongoing
16 Dec 2024LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.DeviceClass II1Ongoing
25 Nov 2024Brand 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: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended…DeviceClass II11Ongoing
19 Nov 2024Duravent Silicone Ventilation Tube. Model Number: 240075.DeviceClass II1Ongoing
31 Oct 2024EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190DeviceClass II1Ongoing
24 Sep 2024Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in…DeviceClass II1Ongoing
18 Sep 2024Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy…DeviceClass II1Ongoing
13 Sep 2024EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. Model/Catalog Number: BD-410X-1055DeviceClass II1Ongoing
13 Sep 2024Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/ADeviceClass II1Ongoing
13 Sep 2024Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;DeviceClass II1Ongoing
11 Sep 2024Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product Description: The Olympus UroPass Ureteral…DeviceClass II1Ongoing
4 Sep 2024Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327UDeviceClass II1Ongoing
23 Aug 2024Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)DeviceClass II1Ongoing
21 Aug 2024Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100DeviceClass II1Ongoing
13 Aug 2024Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLSDeviceClass II2Ongoing
1 Jul 2024The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws…DeviceClass II3Ongoing
21 Jun 2024ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307CDeviceClass II1Ongoing
31 May 2024Soltive Premium SuperPulsed Laser System, Model TFL-PLSDeviceClass II3Ongoing
24 Apr 2024EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and…DeviceClass II1Ongoing
18 Apr 2024OES 4000 Hysteroscope, Model/Catalog Number: A4674ADeviceClass II1Ongoing
3 Apr 2024InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.DeviceClass II1Ongoing
7 Mar 2024POWERSEAL 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-0523CJDADeviceClass II3Ongoing
1 Mar 2024Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640LDeviceClass II2Ongoing
17 Feb 2024Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a…DeviceClass II2Ongoing
29 Jan 2024SOLTIVE Pro SuperPulsed Laser (TFL-SLS )DeviceClass II2Ongoing
16 Jan 2024InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K45BTOL LCS1545TPOL LCS1845TPST LCS4K45TPOL…DeviceClass II1Ongoing
16 Jan 2024Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.DeviceClass II1Ongoing
11 Jan 2024Colonoscope, Model Number CF-H180AL.DeviceClass II10Ongoing
5 Jan 2024Hemostasis Probe, Model: CD-B622LADeviceClass II1Ongoing
15 Dec 2023ESG PK CUTTING FORCEPS, 5MM, 33CMDeviceClass II1Ongoing
11 Dec 2023Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044DeviceClass II1Ongoing
8 Dec 2023Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevatorDeviceClass II1Ongoing
4 Dec 2023SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BSDeviceClass II1Ongoing
4 Dec 2023Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940DeviceClass II2Ongoing
1 Dec 2023SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BSDeviceClass II1Ongoing
20 Nov 2023OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities,…DeviceClass II2Ongoing
10 Nov 2023EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880DeviceClass II12Ongoing
6 Nov 2023Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including…DeviceClass II1Ongoing
12 Oct 2023BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160DeviceClass I6Ongoing
2 Oct 2023ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar…DeviceClass II1Ongoing
2 Oct 2023EVIS EXERA III Gastrointestinal VideoscopeDeviceClass II1Ongoing
28 Sep 2023TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GPDeviceClass II1Ongoing
25 Sep 2023Insufflation unit, UHI-4.DeviceClass II1Ongoing
22 Sep 2023Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.DeviceClass I1Ongoing
14 Sep 2023EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observationDeviceClass II1Ongoing
12 Sep 2023THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis,…DeviceClass II2Ongoing
10 Aug 2023Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-2400 SPiN Drive System SYS-2230 ig4 System V2, 230V, 50Hz…DeviceClass II6Ongoing
27 Jul 2023EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VDeviceClass II1Ongoing
27 Jul 2023Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.DeviceClass II15Ongoing
20 Jul 2023Visera Hysterovideoscope Olympus HYF Type VDeviceClass II1Ongoing
12 Jul 2023The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5DeviceClass II1Ongoing
8 Jun 2023Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60DeviceClass I7Ongoing
8 Jun 2023HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8) A22207C 9) A22211C 10) A22221C 11) A22222C 12) A22223C 13)…DeviceClass II1Ongoing
26 May 2023VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.DeviceClass II5Ongoing
19 May 2023UroPass Ureteral Access Sheaths, 5 pieces/boxDeviceClass II1Ongoing
15 May 2023Always-On Tip Tracked Instruments (SPiN Drive instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing Model: INS-0352DeviceClass II8Ongoing
4 May 2023Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.ADeviceClass II4Ongoing
18 Apr 2023Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100DeviceClass II1Ongoing
31 Mar 2023ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-ADeviceClass III2Ongoing
23 Feb 2023Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clipDeviceClass II1Ongoing
21 Dec 2022EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180ALDeviceClass II1Ongoing
13 Dec 2022SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)DeviceClass II1Ongoing
4 Nov 2022HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657SDeviceClass II1Ongoing
16 Sep 2022Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.DeviceClass II1Ongoing
12 Aug 2022Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.DeviceClass II3Ongoing
7 Jul 2022ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-SDeviceClass II1Ongoing
26 May 2022SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX550S (Carton) - 550 Micron Single Use…DeviceClass II1Terminated
22 Apr 2022Colonovideoscope Model CF-H180ALDeviceClass II1Terminated
22 Apr 2022EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190DeviceClass II1Ongoing
20 Apr 2022Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5DeviceClass II3Ongoing
31 Mar 2022Olympus DISPOSABLE GRASPING FORCEPS, FG-51DDeviceClass II1Terminated
25 Mar 2022Olympus Uretero-reno videoscope, Model No. URF-V2DeviceClass II1Ongoing
18 Mar 2022Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.DeviceClass II1Ongoing
8 Mar 2022BF-MP60: OES BronchofiberscopeDeviceClass II4Ongoing
23 Dec 2021Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00DeviceClass II1Ongoing
13 Dec 2021OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessoriesDeviceClass II1Terminated
2 Nov 2021EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180VDeviceClass II1Ongoing
21 Sep 2021ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during…DeviceClass II1Terminated
17 Aug 2021EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160DeviceClass II1Terminated
16 Aug 2021BF-N20 OES Bronchofiberscope, Model No. BF-N20DeviceClass II10Terminated
3 Aug 2021Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to…DeviceClass II1Terminated
30 Jun 2021Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgeryDeviceClass II1Terminated
9 Jun 2021Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PCDeviceClass II1Terminated
28 Jan 2021Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.DeviceClass II1Terminated
16 Oct 2020Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.DeviceClass II10Terminated
31 Aug 2020Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary…DeviceClass II1Terminated
31 Aug 2020Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).DeviceClass II1Terminated
14 Jul 2020Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168DeviceClass II2Terminated
5 May 2020ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.DeviceClass II1Terminated
23 Apr 2020OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T TransducerDeviceClass II1Terminated
23 Mar 2020Olympus Pleuravideoscope, Model LTF-160DeviceClass II2Terminated
12 Sep 2019Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/packDeviceClass II1Ongoing
10 Jun 2019Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664DeviceClass II1Terminated
1 Apr 2019Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes,…DeviceClass II1Terminated
17 Dec 2018Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.DeviceClass II4Terminated
8 Aug 2018Bronchovideoscope BF-160DeviceClass II30Terminated
11 May 2018Olympus JF-140F duodenoscopes (Model NumberJF-140F)DeviceClass II2Terminated
17 Jan 2018Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2RDeviceClass II1Terminated
17 Jan 2018Uretero-reno fiberscope URF-P6DeviceClass II2Terminated
18 Aug 2017A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and…DeviceClass II1Terminated
19 Apr 2017High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.DeviceClass II1Terminated
10 Feb 2017Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603DeviceClass II1Terminated
12 Dec 2016URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscopeDeviceClass II1Terminated
12 Dec 2016Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.DeviceClass II1Terminated
3 Nov 2016HF Cable WA00014A, Endoscopic electrosurgical unit and accessoriesDeviceClass II1Terminated
23 Jun 2016OER-Pro Endoscope Reprocessor, Endoscope washer/disinfectorDeviceClass II1Terminated
15 Mar 2016EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.DeviceClass II1Terminated
8 Jan 2016Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.DeviceClass II1Terminated
17 Nov 2015Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal…DeviceClass II1Terminated
11 Sep 2015MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.DeviceClass II1Terminated
21 Aug 2015EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Olympus Corporation of the Americas: events for each product type
TypeEvents
Device141
Olympus Corporation of the Americas: events in each class
ClassEvents
Class II131
Class I9
Class III1
Share of the events of the firm in Class I
6%
Share of all events on the register in Class I
18%
Events with the status Ongoing
104

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Olympus Corporation of the Americas, by the year that the recall started. The largest year is 2023, with 31 events.

Official channels

Cite this page

Recall Register. Olympus Corporation of the Americas: FDA recalls. https://recallregister.com/firm/olympus-corporation-of-the-americas/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
PA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Olympus Corporation of the Americas have?
Class II: 131 events. Class I: 9 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Olympus Corporation of the Americas?
FDA event 99607, which the firm started on 18 Aug 2026. The first product in the record is: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
How many FDA recalls of Olympus Corporation of the Americas have the status Ongoing?
104 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.