Olympus Corporation of the Americas

87 recalls on record

Class II2026-04-01

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Olympus Corporation of the Americasdevice

Class II2026-04-01

Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Olympus Corporation of the Americasdevice

Class II2026-04-01

Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Olympus Corporation of the Americasdevice

Class II2026-04-01

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Olympus Corporation of the Americasdevice

Class II2026-04-01

Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.

Olympus Corporation of the Americasdevice

Class II2026-04-01

Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Olympus Corporation of the Americasdevice

Class II2026-04-01

Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Olympus Corporation of the Americasdevice

Class II2026-04-01

Brand 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 visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus Corporation of the Americasdevice

Class II2026-04-01

Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 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 visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus Corporation of the Americasdevice

Class II2026-04-01

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Olympus Corporation of the Americasdevice

Class II2026-04-01

Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

Olympus Corporation of the Americasdevice

Class II2026-03-11

Olympus 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.

Potential for rubber fragment detachment during use.

Olympus Corporation of the Americasdevice

Class II2026-03-11

Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.

Potential for rubber fragment detachment during use.

Olympus Corporation of the Americasdevice

Class II2026-03-11

Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G 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 requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.

Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

Olympus Corporation of the Americasdevice

Class II2026-03-11

Brand 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 is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.

Olympus Corporation of the Americasdevice

Class II2026-03-11

Brand 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 shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.

Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.

Olympus Corporation of the Americasdevice

Class II2026-03-11

Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S 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 requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-03-04

Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class I — Urgent2026-02-25

Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

Issue with software algorithm which may lead to overpressure events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class I — Urgent2026-02-25

Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

Issue with software algorithm which may lead to overpressure events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class I — Urgent2026-02-25

Olympus 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.

Issue with software algorithm which may lead to overpressure events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat, 5 mm, 45 cm Inline Grip

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class II2026-02-25

Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip

Firm is initiating a removal due to continued reports of adverse events.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Brand 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Brand 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 system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L 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 system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class II2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; 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.

Devices which did not undergo thermoforming could deform and lose performance.

Olympus Corporation of the Americasdevice

Class I — Urgent2025-12-03

Brand 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.

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

Olympus Corporation of the Americasdevice

Class II2025-12-03

Brand 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 ancillary equipment for endoscopy and endoscopic surgery.

Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

Olympus Corporation of the Americasdevice