FDA recall record · openFDA
Olympus Corporation of the Americas
295 FDA recalls on record (2023–2026) — 295 device. 295 still ongoing.
44
Class I (most serious)
249
Class II
2
Class III
295
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Devices which did not undergo thermoforming could deform and lose performance. 30
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunct 23
Complaints of the ceramic tip of the resection sheath breaking have been received. 20
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. 15
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events i 12
Recalls
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automat Class I 2026-01-16 Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automa Class I 2026-01-16 Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic Class I 2026-01-16 EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 Class I 2025-09-11 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 Class I 2025-09-11 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 Class I 2025-09-11 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 Class I 2025-09-11 Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide S Class I 2025-01-15 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 Class I 2025-09-11 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 Class I 2025-09-11 BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 Class I 2025-09-11 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC Class I 2025-09-11 BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170 Class I 2025-09-11 ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device Class I 2025-08-06 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 Class I 2025-09-11 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 Class I 2025-09-11 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 Class I 2025-09-11 Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Class I 2025-10-30 BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 Class I 2025-09-11 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 Class I 2025-09-11 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 Class I 2025-09-11 EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 Class I 2025-09-11 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 Class I 2025-09-11 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 Class I 2025-09-11 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 Class I 2025-09-11 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 Class I 2025-09-11 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 Class I 2025-09-11 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 Class I 2025-09-11 BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Class I 2025-09-11 Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is design Class I 2024-12-18 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 Class I 2023-10-12 Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 Class I 2023-06-08 Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190 Class I 2023-06-08 Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. Class I 2023-09-22 EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190 Class I 2023-10-12 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYM Class I 2023-10-12 Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170 Class I 2023-06-08 Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 Class I 2023-06-08 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180 Class I 2023-10-12 EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Class I 2023-10-12 Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60 Class I 2023-06-08 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC Class I 2023-10-12 Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150 Class I 2023-06-08 Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180 Class I 2023-06-08 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instr Class II 2026-01-07 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These ins Class II 2026-01-07 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC. Class II 2026-03-23 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115. Class II 2026-03-25 Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be Class II 2026-01-29 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Class II 2026-01-07 Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to Class II 2026-01-29 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Class II 2026-01-07 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Prod Class II 2026-02-25 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. Class II 2026-03-23 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These ins Class II 2026-01-07 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instr Class II 2026-01-07 Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. Class II 2026-02-12 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113. Class II 2026-03-25 Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 92000 Class II 2026-02-25 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These ins Class II 2026-01-07 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These ins Class II 2026-01-07 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Class II 2026-01-07 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These ins Class II 2026-01-07 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Class II 2026-01-07 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Class II 2026-01-07 Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. Class II 2026-02-12 Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/ Class II 2026-02-27 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Class II 2026-01-07 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119. Class II 2026-03-25 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These ins Class II 2026-01-07 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114. Class II 2026-03-25 Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Class II 2026-01-07 Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Pro Class II 2026-02-25 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software V Class II 2026-01-07 Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. Class II 2026-02-12 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138. Class II 2026-03-25 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Class II 2026-01-07 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Class II 2026-01-07 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118. Class II 2026-03-25 Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. Class II 2026-02-12 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Class II 2026-01-07 Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Ca Class II 2026-02-25 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instr Class II 2026-01-07 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC. Class II 2026-03-23 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 Class II 2026-03-25 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instr Class II 2026-01-07 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117. Class II 2026-03-25 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Class II 2026-01-07 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Class II 2026-01-07 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OE Class II 2026-03-25 Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC. Class II 2026-03-23 Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Class II 2026-02-27 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 Class II 2026-03-25 Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Class II 2026-01-07 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Class II 2026-01-07 Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Descriptio Class II 2026-01-07 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instr Class II 2026-01-07 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. Class II 2026-03-25 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These ins Class II 2026-01-07 Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Mo Class II 2026-02-25 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Class II 2026-01-07 Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Pr Class II 2026-02-25 Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HA Class II 2026-02-25 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Class II 2026-01-07 Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Re Class II 2026-01-08 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330. Class II 2026-03-25 Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Prod Class II 2025-10-08 Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S Class II 2025-10-22 Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SE Class II 2025-07-25 Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip Class II 2025-10-22 Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications. Class II 2025-11-11 Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Class II 2025-11-14 Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite Class II 2025-06-18 Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applicatio Class II 2025-11-11 Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are Class II 2025-06-18 Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications. Class II 2025-11-11 Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S Class II 2025-10-22 Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications. Class II 2025-11-11 Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications. Class II 2025-11-11 Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applicatio Class II 2025-11-11 Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalo Class II 2025-05-06 Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications. Class II 2025-11-11 Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications. Class II 2025-11-11 Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V Class II 2025-05-05 Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic application Class II 2025-11-11 Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip Class II 2025-10-22 Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessor Class II 2025-06-18 Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephro Class II 2025-10-17 Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications. Class II 2025-11-11 Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications. Class II 2025-11-11 Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications. Class II 2025-11-11 Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible w Class II 2025-06-18 Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications. Class II 2025-11-11 Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers Class II 2025-04-04 Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Class II 2025-10-22 Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgi Class II 2025-10-06 Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications. Class II 2025-11-11 Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip Class II 2025-10-22 Olympus Thunderbeat 5 mm, 10 cm, Inline Grip Class II 2025-10-22 Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible w Class II 2025-06-18 Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications. Class II 2025-11-11 Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications. Class II 2025-11-11 Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Class II 2025-10-14 Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications. Class II 2025-11-11 Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible Class II 2025-06-18 Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone se Class II 2025-06-18 Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes M Class II 2025-11-14 Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. Class II 2025-07-25 Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catal Class II 2025-10-06 Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applicatio Class II 2025-11-11 Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications. Class II 2025-11-11 Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Num Class II 2025-05-06 Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S Class II 2025-10-22 Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications. Class II 2025-11-11 Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FB Class II 2025-05-06 Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip Class II 2025-10-22 Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip Class II 2025-10-22 Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: Class II 2025-05-06 Olympus Thunderbeat, 5 mm, 45 cm Inline Grip Class II 2025-10-22 Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the b Class II 2025-06-18 Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Class II 2025-10-22 Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Class II 2025-11-14 Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U Class II 2024-09-04 The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou Class II 2024-07-01 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front- Class II 2024-11-25 Colonoscope, Model Number PCF-H190DL. Class II 2024-01-11 Colonoscope, Model Number CF-Q180AL. Class II 2024-01-11 Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Produ Class II 2024-09-13 Colonoscope, Model Number CF-H180AL. Class II 2024-01-11 Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for pr Class II 2024-01-16 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a Class II 2024-11-25 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front Class II 2024-11-25 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a Class II 2024-11-25 EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilat Class II 2024-09-13 Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100 Class II 2024-08-21 Duravent Silicone Ventilation Tube. Model Number: 240075. Class II 2024-11-19 Colonoscope, Model Number PCF-H180AL. Class II 2024-01-11 Colonoscope, Model Number CF-HQ190L. Class II 2024-01-11 Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038 Class II 2024-09-11 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front- Class II 2024-11-25 SOLTIVE Pro SuperPulsed Laser (TFL-SLS ) Class II 2024-01-29 InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Mod Class II 2024-01-16 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front- Class II 2024-11-25 POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur Class II 2024-03-07 Soltive Premium SuperPulsed Laser System, Model TFL-PLS Class II 2024-05-31 SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) Class II 2024-01-29 Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and v Class II 2024-08-13 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a Class II 2024-11-25 Colonoscope, Model Number PCF-Q180AL. Class II 2024-01-11 Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Cata Class II 2024-02-17 Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Numbe Class II 2024-09-18 The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou Class II 2024-07-01 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Gri Class II 2024-11-25 Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Mode Class II 2024-02-17 Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141) Class II 2024-08-23 Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue Class II 2024-03-01 EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a to Class II 2024-04-24 Colonoscope, Model Number CF-HQ190I. Class II 2024-01-11 InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid en Class II 2024-04-03 Colonoscope, Model Number PCF-HQ190L. Class II 2024-01-11 EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 Class II 2024-10-31 Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; Class II 2024-09-13 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front- Class II 2024-11-25 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front- Class II 2024-11-25 Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue Class II 2024-03-01 ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation Class II 2024-06-21 Colonoscope, Model Number PCF-H190TL. Class II 2024-01-11 Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front- Class II 2024-11-25 POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur Class II 2024-03-07 The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou Class II 2024-07-01 Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and Class II 2024-08-13 OES 4000 Hysteroscope, Model/Catalog Number: A4674A Class II 2024-04-18 POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur Class II 2024-03-07 Colonoscope, Model Number PCF-H190L. Class II 2024-01-11 Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL Class II 2024-05-31 LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V u Class II 2024-12-16 Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is Class II 2024-09-24 Soltive Pro SuperPulsed Laser System, Model TFL-SLS Class II 2024-05-31 Hemostasis Probe, Model: CD-B622LA Class II 2024-01-05 Olympus Bronchovideoscope, Models BF-3C40 & BF-N20. Class II 2023-07-27 EVIS EXERA III Gastrointestinal Videoscope Class II 2023-10-02 The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEO Class II 2023-07-12 OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, l Class II 2023-11-20 Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in cli Class II 2023-05-15 EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults a Class II 2023-11-10 EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light Class II 2023-09-14 Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19 Class II 2023-08-10 EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adult Class II 2023-11-10 SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX Class II 2023-12-01 Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-A Class II 2023-12-04 Olympus Bronchovideoscope, Models BF-3C160. Class II 2023-07-27 Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V. Class II 2023-07-27 Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Class II 2023-12-11 EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adoles Class II 2023-11-10 Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olym Class II 2023-12-08 Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical Class II 2023-05-15 Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display m Class II 2023-05-26 HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatme Class II 2023-06-08 Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Class II 2023-05-04 Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160. Class II 2023-07-27 Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interv Class II 2023-05-15 Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60. Class II 2023-07-27 Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Alw Class II 2023-08-10 Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical int Class II 2023-05-15 Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Class II 2023-08-10 Olympus Bronchovideoscope, Models BF-P190 & BF-XP190. Class II 2023-07-27 Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2. Class II 2023-07-27 EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults a Class II 2023-11-10 TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP Class II 2023-09-28 Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexibl Class II 2023-05-26 THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including sing Class II 2023-09-12 Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F. Class II 2023-07-27 EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado Class II 2023-11-10 Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexib Class II 2023-05-26 Insufflation unit, UHI-4. Class II 2023-09-25 Visera Hysterovideoscope Olympus HYF Type V Class II 2023-07-20 EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in a Class II 2023-11-10 Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-56 Class II 2023-08-10 EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adult Class II 2023-11-10 Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP. Class II 2023-07-27 Olympus Bronchovideoscope, Model BF-Q180-AC Class II 2023-07-27 Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Nu Class II 2023-05-04 Olympus Bronchovideoscope, Models BF-MP190F. Class II 2023-07-27 EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V Class II 2023-07-27 Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use Class II 2023-05-15 EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and Class II 2023-11-10 Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Class II 2023-05-04 OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, lig Class II 2023-11-20 UroPass Ureteral Access Sheaths, 5 pieces/box Class II 2023-05-19 ESG PK CUTTING FORCEPS, 5MM, 33CM Class II 2023-12-15 Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical int Class II 2023-05-15 SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS Class II 2023-12-04 Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: C Class II 2023-04-18 VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to Class II 2023-05-26 Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use Class II 2023-05-15 Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 Class II 2023-08-10 Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Ac Class II 2023-08-10 Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Class II 2023-02-23 EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in Class II 2023-11-10 Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light sou Class II 2023-11-06 EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adul Class II 2023-11-10 Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190. Class II 2023-07-27 Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180. Class II 2023-07-27 Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in c Class II 2023-05-15 Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC Class II 2023-12-04 Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Nu Class II 2023-05-04 Olympus Bronchovideoscope, Models BF-XT190. Class II 2023-07-27 THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including singl Class II 2023-09-12 Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible Class II 2023-05-26 ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loo Class II 2023-10-02 Olympus Airway Mobilescope, Models MAF-GM & MAF-TM. Class II 2023-07-27 EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado Class II 2023-11-10 EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado Class II 2023-11-10 ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle as Class III 2023-03-31 To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural le Class III 2023-03-31
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.