PlainRecalls

Olympus Corporation of the Americas

Compiled from official public sources by the editorial team.

407 recalls on record · Latest: Apr 29, 2026

Olympus Corporation of the Americas Recall Insight

Olympus Corporation of the Americas appears on 407 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.400% 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 Apr 29, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 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 Jun 17, 2020 to Oct 5, 2022.

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 5, 2022

Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopi…

FDA Devices Moderate Oct 5, 2022

Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopi…

FDA Devices Moderate Aug 17, 2022

ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

FDA Devices Moderate Jul 6, 2022

SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) -…

FDA Devices Moderate Jun 29, 2022

EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model…

FDA Devices Moderate Jun 29, 2022

Colonovideoscope Model CF-H180AL

FDA Devices Moderate Jun 22, 2022

Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

FDA Devices Moderate Jun 22, 2022

Olympus URETERO-RENO FIBERSCOPE Model: URF-P6

FDA Devices Moderate Jun 22, 2022

Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

FDA Devices Moderate Jun 1, 2022

Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

FDA Devices Moderate May 25, 2022

Olympus Uretero-reno videoscope, Model No. URF-V2

FDA Devices Moderate May 18, 2022

BF-3C160: EVIS EXERA Bronchovideoscope

FDA Devices Moderate May 18, 2022

BF-MP160F: EVIS EXERA Bronchofibervideoscope

FDA Devices Moderate May 18, 2022

BF-MP60: OES Bronchofiberscope

FDA Devices Moderate May 18, 2022

BF-1TQ180: EVIS EXERA II Bronchovideoscope

FDA Devices Moderate May 11, 2022

Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.

FDA Devices Moderate Feb 23, 2022

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and…

FDA Devices Moderate Feb 9, 2022

Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflat…

FDA Devices Moderate Dec 22, 2021

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

FDA Devices Moderate Nov 3, 2021

ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue co…

FDA Devices Moderate Oct 6, 2021

BF-XP60 OES Bronchofiberscope, Model No. BF-XP60

FDA Devices Moderate Oct 6, 2021

BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180

FDA Devices Moderate Oct 6, 2021

BF-3C40 OES Bronchofiberscope, Model No. BF-3C40

FDA Devices Moderate Oct 6, 2021

BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160

FDA Devices Moderate Oct 6, 2021

BF-1T60 OES Bronchofiberscope, Model No. BF-1T60

FDA Devices Moderate Oct 6, 2021

BF-N20 OES Bronchofiberscope, Model No. BF-N20

FDA Devices Moderate Oct 6, 2021

BF-P60 OES Bronchofiberscope, Model No. BF-P60

FDA Devices Moderate Oct 6, 2021

BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC

FDA Devices Moderate Oct 6, 2021

BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F

FDA Devices Moderate Oct 6, 2021

BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180

FDA Devices Moderate Sep 29, 2021

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

FDA Devices Moderate Sep 15, 2021

Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 …

FDA Devices Moderate Sep 8, 2021

Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of la…

FDA Devices Moderate Aug 25, 2021

Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, …

FDA Devices Moderate Mar 31, 2021

Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monito…

FDA Devices Moderate Dec 9, 2020

Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound …

FDA Devices Moderate Dec 9, 2020

Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human…

FDA Devices Moderate Dec 9, 2020

Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile a…

FDA Devices Moderate Dec 9, 2020

Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging…

FDA Devices Moderate Dec 9, 2020

Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, l…

FDA Devices Moderate Dec 9, 2020

Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic sy…

FDA Devices Moderate Dec 9, 2020

Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human…

FDA Devices Moderate Dec 9, 2020

Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, li…

FDA Devices Moderate Dec 9, 2020

Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound i…

FDA Devices Moderate Dec 9, 2020

Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.

FDA Devices Moderate Oct 28, 2020

Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-…

FDA Devices Moderate Oct 7, 2020

Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designe…

FDA Devices Moderate Aug 26, 2020

Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662

FDA Devices Moderate Aug 26, 2020

Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168

FDA Devices Moderate Jun 17, 2020

ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.