PlainRecalls

Olympus Corporation of the Americas

Compiled from official public sources by the publisher.

414 recalls on record · Latest: Jul 29, 2026

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Agency notice ledger

Federal filing book Olympus Corporation HEAVY-BOOK · SINGLE-AGENCY

#20 of 14,151 · 414 notices · 0.396% archive

  • BOOK 414 notices
  • RANK #20 of 14,151
  • SHARE 0.396% archive
  • AGENCY FDA Devices (414)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 29, 2026
  • PHOTO Baxter Healthcare Cor…

Nearest notice-volume peer: Baxter Healthcare Corporation (1 notice gap)

Olympus Corporation of the Americas accounts for about 0.396% of the 104,423-notice archive on 414 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Olympus Corporation's standing among 14,151 recalling firms

Olympus Corporation of the Americas ranks 20th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Olympus Corporation vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

414 20th of 14151 higher than 14,131 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Olympus Corporation in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Olympus Corporation of the Americas holds about 0.396% of archive notices alongside 414 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jul 29, 2026

Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
FDA Devices Moderate Jul 29, 2026

Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
FDA Devices Moderate Jul 22, 2026

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
FDA Devices Moderate Jul 22, 2026

Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
FDA Devices Moderate Jul 22, 2026

Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
FDA Devices Moderate Jul 22, 2026

Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
FDA Devices Moderate Jul 15, 2026

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
FDA Devices Moderate Apr 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
FDA Devices Moderate Apr 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
FDA Devices Moderate Apr 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
FDA Devices Moderate Apr 29, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
FDA Devices Moderate Apr 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
FDA Devices Moderate Apr 8, 2026

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
FDA Devices Moderate Apr 8, 2026

Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
FDA Devices Moderate Apr 1, 2026

Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
FDA Devices Moderate Apr 1, 2026

Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.
FDA Devices Moderate Apr 1, 2026

Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
FDA Devices Moderate Apr 1, 2026

Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
FDA Devices Moderate Apr 1, 2026

Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.
FDA Devices Moderate Mar 11, 2026

Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
FDA Devices Moderate Mar 11, 2026

Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
FDA Devices Moderate Mar 11, 2026

Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly dis
FDA Devices Moderate Mar 11, 2026

Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy th
FDA Devices Moderate Mar 11, 2026

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically

FDA Devices Moderate Mar 11, 2026

Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy th
FDA Devices Moderate Mar 4, 2026

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
FDA Devices Moderate Mar 4, 2026

Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
FDA Devices Moderate Mar 4, 2026

Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
FDA Devices Moderate Mar 4, 2026

Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
FDA Devices Moderate Mar 4, 2026

Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
FDA Devices Moderate Mar 4, 2026

Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

Olympus Corporation carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Baxter Healthcare Corporation 413 Biomerieux Inc 422 Philips North America Llc 404 Zimmer, Inc. 446

Frequently Asked Questions

How many federal recall notices name Olympus Corporation? ▼
PlainRecalls indexes 414 distinct federal recall events naming Olympus Corporation of the Americas, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Olympus Corporation sit among other recalling firms? ▼
Olympus Corporation of the Americas ranks #20 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Olympus Corporation's notices? ▼
FDA Devices accounts for 414 of this firm's 414 indexed notices.
What product category dominates Olympus Corporation's filing book? ▼
Filings for Olympus Corporation of the Americas span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Olympus Corporation of the Americas: 414 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Olympus Corporation of the Americas; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026