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 7 critical, 43 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 11, 2023 to Oct 30, 2024.

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 Oct 30, 2024

Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, …

FDA Devices Moderate Oct 23, 2024

EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoThera…

FDA Devices Moderate Sep 18, 2024

Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current …

FDA Devices Moderate Aug 14, 2024

The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forc…

FDA Devices Moderate Aug 14, 2024

Soltive Premium SuperPulsed Laser System, Model TFL-PLS

FDA Devices Moderate Aug 14, 2024

The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forc…

FDA Devices Moderate Jul 10, 2024

EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for …

FDA Devices Moderate May 8, 2024

POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic…

FDA Devices Moderate Apr 3, 2024

Insufflation unit, UHI-4.

FDA Devices Moderate Apr 3, 2024

SOLTIVE Pro SuperPulsed Laser (TFL-SLS )

FDA Devices Moderate Apr 3, 2024

InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1…

FDA Devices Moderate Apr 3, 2024

SOLTIVE Premium SuperPulsed Laser (TFL-PLS )

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number PCF-H190DL.

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number CF-Q180AL.

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number CF-H180AL.

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number PCF-H180AL.

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number CF-HQ190L.

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number PCF-Q180AL.

FDA Devices Moderate Mar 6, 2024

Colonoscope, Model Number CF-HQ190I.

FDA Devices Moderate Feb 28, 2024

ESG PK CUTTING FORCEPS, 5MM, 33CM

FDA Devices Moderate Feb 21, 2024

Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cov…

FDA Devices Moderate Feb 14, 2024

Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044

FDA Devices Moderate Feb 14, 2024

Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the ri…

FDA Devices Moderate Feb 7, 2024

EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) M…

FDA Devices Moderate Feb 7, 2024

EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years)…

FDA Devices Moderate Feb 7, 2024

EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD…

FDA Devices Moderate Feb 7, 2024

EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). …

FDA Devices Moderate Feb 7, 2024

EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model:…

FDA Devices Moderate Feb 7, 2024

EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 ye…

FDA Devices Moderate Feb 7, 2024

EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years)…

FDA Devices Moderate Feb 7, 2024

EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Mo…

FDA Devices Moderate Jan 24, 2024

SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS

FDA Devices Moderate Jan 24, 2024

Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940

FDA Devices Moderate Jan 24, 2024

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

FDA Devices Moderate Jan 17, 2024

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation eq…

FDA Devices Moderate Jan 17, 2024

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equi…

FDA Devices Moderate Dec 20, 2023

TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

FDA Devices Critical Nov 15, 2023

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190

FDA Devices Moderate Nov 15, 2023

EVIS EXERA III Gastrointestinal Videoscope

FDA Devices Critical Nov 15, 2023

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190

FDA Devices Critical Nov 15, 2023

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160

FDA Devices Critical Nov 15, 2023

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180

FDA Devices Critical Nov 15, 2023

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170

FDA Devices Critical Nov 15, 2023

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC

FDA Devices Critical Oct 25, 2023

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

FDA Devices Moderate Oct 18, 2023

THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surg…

FDA Devices Moderate Oct 11, 2023

Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/…

FDA Devices Moderate Oct 11, 2023

Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Track…

FDA Devices Moderate Oct 11, 2023

Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System …

FDA Devices Moderate Oct 11, 2023

Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Ne…

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