PlainRecalls

Olympus Corporation of the Americas

259 recalls on record · Latest: Mar 11, 2026

Olympus Corporation of the Americas Recall Insight

Olympus Corporation of the Americas appears on 259 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.309% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 18 critical, 32 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Oct 30, 2024 to Feb 11, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Feb 11, 2026

Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Pr…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to …

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instrumen…

FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Descrip…

FDA Devices Critical Dec 3, 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…

FDA Devices Moderate Nov 26, 2025

Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model…

FDA Devices Moderate Nov 19, 2025

Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPul…

FDA Devices Moderate Nov 19, 2025

Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Numb…

FDA Devices Critical Oct 22, 2025

EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

FDA Devices Critical Oct 22, 2025

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

FDA Devices Critical Oct 22, 2025

BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

FDA Devices Critical Oct 22, 2025

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60

FDA Devices Critical Oct 22, 2025

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150

FDA Devices Critical Oct 22, 2025

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180

FDA Devices Critical Oct 22, 2025

BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100

FDA Devices Critical Oct 22, 2025

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC

FDA Devices Critical Oct 22, 2025

BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170

FDA Devices Critical Oct 22, 2025

BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2

FDA Devices Critical Oct 22, 2025

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

FDA Devices Critical Oct 22, 2025

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180

FDA Devices Critical Oct 22, 2025

BRONCHOVIDEOSCOPE OLYMPUS BF-H1100

FDA Devices Critical Oct 22, 2025

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150

FDA Devices Critical Sep 17, 2025

ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts…

FDA Devices Moderate Aug 27, 2025

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. …

FDA Devices Moderate Jul 30, 2025

Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

FDA Devices Moderate Jul 30, 2025

Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI El…

FDA Devices Moderate Jul 30, 2025

Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus…

FDA Devices Moderate Jul 30, 2025

Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elit…

FDA Devices Moderate Jul 30, 2025

Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elit…

FDA Devices Moderate Jun 18, 2025

Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-…

FDA Devices Moderate Jun 11, 2025

Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V

FDA Devices Moderate May 7, 2025

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product D…

FDA Devices Critical Feb 19, 2025

Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel…

FDA Devices Moderate Jan 29, 2025

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model N…

FDA Devices Moderate Jan 29, 2025

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…

FDA Devices Moderate Jan 29, 2025

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model …

FDA Devices Moderate Jan 29, 2025

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…

FDA Devices Moderate Jan 29, 2025

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model N…

FDA Devices Moderate Jan 29, 2025

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model N…

FDA Devices Moderate Jan 29, 2025

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Nu…

FDA Devices Moderate Jan 29, 2025

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-05…

FDA Devices Critical Jan 22, 2025

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the inst…

FDA Devices Moderate Dec 25, 2024

Duravent Silicone Ventilation Tube. Model Number: 240075.

FDA Devices Moderate Nov 27, 2024

Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Versi…

FDA Devices Moderate Nov 20, 2024

Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths…

FDA Devices Moderate Nov 20, 2024

Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX…

FDA Devices Moderate Nov 6, 2024

Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

FDA Devices Moderate Nov 6, 2024

Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)

FDA Devices Moderate Oct 30, 2024

EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentar…

FDA Devices Moderate Oct 30, 2024

Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds