Olympus Corporation of the Americas Recalls

100 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (100)

March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
XXX
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Class II
March 23, 2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Potential for detachment of a distal tip component of the device during use.
Class II
March 23, 2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Potential for detachment of a distal tip component of the device during use.
Class II
March 23, 2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Potential for detachment of a distal tip component of the device during use.
Class II
March 23, 2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Potential for detachment of a distal tip component of the device during use.
Class II
February 27, 2026
Brand 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
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Class II
February 27, 2026
Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Class II
February 25, 2026
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 Cutti
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.
Class II
February 25, 2026
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 For
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.
Class II
February 25, 2026
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 5
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.
Class II
February 25, 2026
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-fr
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.
Class II
February 25, 2026
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 pas
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.
Class II
February 25, 2026
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
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.
Class II
February 25, 2026
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 thro
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.
Class II
February 12, 2026
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.
Class II
February 12, 2026
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.
Class II
February 12, 2026
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.
Class II
February 12, 2026
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.
Class II
January 29, 2026
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 ref
Potential for rubber fragment detachment during use.
Class II
January 29, 2026
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 l
Potential for rubber fragment detachment during use.
Class II
January 16, 2026
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 treat
Issue with software algorithm which may lead to overpressure events.
Class I
January 16, 2026
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 trea
Issue with software algorithm which may lead to overpressure events.
Class I
January 16, 2026
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 treatme
Issue with software algorithm which may lead to overpressure events.
Class I
January 8, 2026
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
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.
Class II
January 7, 2026
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 f
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 u
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 f
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 en
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 us
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 us
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 en
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 us
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 f
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 en
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 en
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 f
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 us
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 f
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 f
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 us
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 en
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 u
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 f
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 use
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 en
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 us
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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
Devices which did not undergo thermoforming could deform and lose performance.
Class II
January 7, 2026
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 us
Devices which did not undergo thermoforming could deform and lose performance.
Class II
November 14, 2025
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 Sys
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.
Class II
November 14, 2025
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 Sys
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.
Class II
November 14, 2025
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 elec
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
November 11, 2025
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.
Class II
October 30, 2025
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.
Class I
October 22, 2025
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
October 22, 2025
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Class II
October 22, 2025
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
October 22, 2025
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
October 22, 2025
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
October 22, 2025
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
October 22, 2025
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Class II
October 22, 2025
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
October 22, 2025
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II
October 22, 2025
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Class II
October 22, 2025
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
Class II

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