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Olympus Corporation of the Americas — recalls

102 recall record(s) involving Olympus Corporation of the Americas, from official U.S. government sources.

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. · Medical Device · April 29, 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113. · Medical Device · April 29, 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117. · Medical Device · April 29, 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 · Medical Device · April 29, 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 · Medical Device · April 29, 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330. · Medical Device · April 29, 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OE · Medical Device · April 29, 2026Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC. · Medical Device · April 29, 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114. · Medical Device · April 29, 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119. · Medical Device · April 29, 2026Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. · Medical Device · April 29, 2026Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC. · Medical Device · April 29, 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138. · Medical Device · April 29, 2026Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC. · Medical Device · April 29, 2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118. · Medical Device · April 29, 2026Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog · Medical Device · April 08, 2026Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/ · Medical Device · April 08, 2026Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. · Medical Device · April 01, 2026Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. · Medical Device · April 01, 2026Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Prod · Medical Device · April 01, 2026Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. · Medical Device · April 01, 2026Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Pro · Medical Device · April 01, 2026Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 92000 · Medical Device · April 01, 2026Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Pr · Medical Device · April 01, 2026Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. · Medical Device · April 01, 2026Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HA · Medical Device · April 01, 2026Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Mo · Medical Device · April 01, 2026Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Ca · Medical Device · April 01, 2026Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes · Medical Device · March 11, 2026Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Re · Medical Device · March 11, 2026Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to · Medical Device · March 11, 2026Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog · Medical Device · March 11, 2026Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be · Medical Device · March 11, 2026Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes M · Medical Device · March 11, 2026Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic application · Medical Device · March 04, 2026Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications. · Medical Device · March 04, 2026Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications. · Medical Device · March 04, 2026Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications. · Medical Device · March 04, 2026Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications. · Medical Device · March 04, 2026Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications. · Medical Device · March 04, 2026Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications. · Medical Device · March 04, 2026Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; · Medical Device · March 04, 2026Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications. · Medical Device · March 04, 2026Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications. · Medical Device · March 04, 2026Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications. · Medical Device · March 04, 2026Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications. · Medical Device · March 04, 2026Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications. · Medical Device · March 04, 2026Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applicatio · Medical Device · March 04, 2026Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications. · Medical Device · March 04, 2026Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications. · Medical Device · March 04, 2026Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications. · Medical Device · March 04, 2026Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applicatio · Medical Device · March 04, 2026Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applicatio · Medical Device · March 04, 2026Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications. · Medical Device · March 04, 2026Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications. · Medical Device · March 04, 2026Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S · Medical Device · February 25, 2026Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S · Medical Device · February 25, 2026Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip · Medical Device · February 25, 2026Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip · Medical Device · February 25, 2026Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automa · Medical Device · February 25, 2026Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic · Medical Device · February 25, 2026Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automat · Medical Device · February 25, 2026Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip · Medical Device · February 25, 2026Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S · Medical Device · February 25, 2026Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These ins · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product · Medical Device · February 11, 2026Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These ins · Medical Device · February 11, 2026Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software · Medical Device · February 11, 2026Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These ins · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software · Medical Device · February 11, 2026Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These ins · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instr · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instr · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software · Medical Device · February 11, 2026Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Descriptio · Medical Device · February 11, 2026Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog · Medical Device · February 11, 2026Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These ins · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software · Medical Device · February 11, 2026Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These ins · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instr · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software · Medical Device · February 11, 2026Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Mode · Medical Device · February 11, 2026Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These ins · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instr · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instr · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software · Medical Device · February 11, 2026Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Cata · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product · Medical Device · February 11, 2026Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software V · Medical Device · February 11, 2026Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product · Medical Device · December 03, 2025Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an · Medical Device · December 03, 2025Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephro · Medical Device · November 26, 2025Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catal · Medical Device · November 19, 2025Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgi · Medical Device · November 19, 2025Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Prod · Medical Device · November 19, 2025