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 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 be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
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 instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
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 Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Devices Moderate Feb 11, 2026

Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Devices Moderate Feb 11, 2026

Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Devices Moderate Feb 11, 2026

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Devices Moderate Feb 11, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
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 a nylon loop snare.
FDA Devices Moderate Dec 3, 2025

Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
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/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length
FDA Devices Moderate Nov 19, 2025

Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T 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 disintegrates stones.

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 Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
FDA Devices Moderate Nov 19, 2025

Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
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 Oct 22, 2025

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
FDA Devices Critical Oct 22, 2025

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
FDA Devices Critical Oct 22, 2025

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
FDA Devices Critical Oct 22, 2025

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
FDA Devices Critical Oct 22, 2025

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
FDA Devices Critical Oct 22, 2025

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
FDA Devices Critical Oct 22, 2025

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
FDA Devices Critical Oct 22, 2025

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
FDA Devices Critical Oct 22, 2025

BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
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: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
FDA Devices Moderate Aug 27, 2025

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Devices Moderate Aug 27, 2025

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
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 Elite and Elite 2 Resection Sheaths.
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 ACMI Elite and Elite 2 Resection Sheaths.
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 Elite 2 Resection Sheaths.
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 Elite 2 Resection Sheaths.
FDA Devices Moderate Jul 30, 2025

Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
FDA Devices Moderate Jul 30, 2025

Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
FDA Devices Moderate Jul 30, 2025

Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.

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