Duodenoscopes · Bronchoscopes · Gastroscopes · Colonoscopes
A family of Olympus endoscopes — most prominently the TJF-Q180V and TJF-Q190V duodenoscopes — was designed in a way that prevents adequate cleaning between patients, exposing patients to multidrug-resistant bacterial infections including CRE, KPC, NDM-1, AmpC-producing E. coli, and VIM-2 P. aeruginosa. Olympus admitted to three federal misdemeanor counts and paid $85M in December 2018; product-liability litigation continues across multiple jurisdictions.
Quick facts
The case in one sentence
The Olympus reusable endoscope infection litigation arises from a family of duodenoscopes, bronchoscopes, gastroscopes, and colonoscopes — most prominently the TJF-Q180V and TJF-Q190V duodenoscopes — that were designed in a way that prevents adequate cleaning between patients, exposing patients to multidrug-resistant bacterial infections.
Devices at issue
The litigation reaches well beyond the original duodenoscope cluster. Recent recalls (Oct 2024 – Feb 2026) extend exposure into bronchoscopes, gastroscopes, colonoscopes, and reprocessing accessories.
TJF-Q180V
May 2010 – 2019 · ~4,400 U.S. units · withdrawn after FDA transition recommendation
TJF-Q190V
FDA-cleared Jan 17, 2020 (K193182) · Class 2 recall Z-2467-2023, Jul 2023
TJF-Q170V
Subject to Olympus Worldwide Field Safety Notice (Oct 2025)
TJF-Q290V
Subject to Olympus Worldwide Field Safety Notice (Oct 2025)
BF-1TH190
Class 1 recalls (2023, 2024, 2025)
BF-Q190
Class 1 recalls (2023, 2024, 2025)
BF-P190
Class 1 recalls (2023, 2024, 2025)
BF-H190
Class 1 recalls (2023, 2024, 2025)
BF-1TQ290 family
Class 1 recalls (2023, 2024, 2025)
GIF-1TH190
K232997 cleared Jun 2024 · reprocessing-compatibility recall Oct 2024
CF-H180AL
Subject to litigation
CF-HQ190L
The Collett v. Olympus device (M.D. Ga.)
MAJ-891 forceps/irrigation plug
Class 1 recall Dec 18, 2024 — 120 injuries, 1 death
MAJ-2315 single-use distal cover
Class 2 recall Apr 2025
MAJ-1443 / MAJ-1444 valves
Feb 12, 2026 customer letter · 89,579 units · 7 infection complaints · "NO LONGER REPROCESSING COMPATIBLE"
OER-Pro / OER-Elite / OER-Mini
Automated endoscope reprocessors
Defendants
| Entity | Role | Address |
|---|---|---|
| Olympus Medical Systems Corp. (OMSC) | Japanese manufacturer · 2018 federal criminal plea defendant | Hachioji-shi, Tokyo, Japan |
| Olympus America Inc. (OAI) | U.S. distribution subsidiary · NY-domestic corporation | 3500 Corporate Parkway, Center Valley, PA |
| Olympus Corporation of the Americas (OCA) | U.S. holding company · NY-domestic · Florida-qualified Feb 18, 2026 | 3500 Corporate Parkway, Center Valley, PA |
| Olympus Corporation (TYO: 7733) | Ultimate Japanese parent · FDA Owner/Operator Number 9067818 | Tokyo Stock Exchange listed |
Key facts
70%
Global endoscope market share
Olympus's own 2017 IR disclosure
$85M
Federal criminal plea (Dec 2018)
$80M fine + $5M forfeiture · D.N.J. No. 18-cr-00727
1st
DOJ individual prosecution of a Japan-based med-device exec
United States v. Hisao Yabe (D.N.J. 2018)
25+
U.S. hospitals affected
Senate HELP Committee Report (Jan 13, 2016)
250+
Documented infections
Senate HELP "Preventable Tragedies" report
35+
Deaths attributable
Senate HELP "Preventable Tragedies" report
$6.6M
Bigler v. Olympus verdict
King Cty. WA · Jul 26, 2017 · failure-to-warn theory
5
FDA Warning Letters
OMSC + Aizu Olympus · Jun 2017 – Mar 2023
47-58
Device models on FDA Import Alert 89-04
Detain-without-physical-examination · Jun 24, 2025
89,579
MAJ-1443/1444 valve units recalled
Z-1611-2026 · Feb 12, 2026 · 7 infection complaints
Regulatory history
Olympus sold the TJF-Q180V duodenoscope in the U.S. starting May 2010 WITHOUT 510(k) clearance. The retroactive K143153 clearance was not granted until January 15, 2016 — nearly six years later — and only after the UCLA outbreak forced public disclosure.
Between November 2012 and February 2015, Olympus issued European-only Field Safety Notices through national competent authorities (Netherlands, Germany, France, UK, Belgium, Italy) and distributed an updated cleaning brush (MAJ-1888) to European hospitals starting in 2013. U.S. customers received no equivalent communication until February 19, 2015 — and U.S. distribution of the MAJ-1888 brush did not begin until May 2015. Olympus's federal criminal plea (Dec 10, 2018) admitted the company concealed this European data from FDA.
Litigation significance
These two facts — six-year unauthorized U.S. sale + concealment of European safety data — convert what would otherwise be a design-defect case into a fraudulent-concealment case anchored by a federal criminal plea admission. That is the single strongest factual predicate available for punitive damages in any current pharmaceutical or medical-device docket.
Causes of action supported
Strict product liability — design defect
Closed-elevator-channel architecture
Strict product liability — failure to warn
European safety notices withheld from U.S. market 2012-2015
Negligence
Design, manufacturing, reprocessing-protocol validation, post-market surveillance
Fraudulent concealment
Anchored by federal criminal plea admissions (Dec 2018)
Negligent misrepresentation
Inaccurate reprocessing IFU representations
Breach of express and implied warranties
Reprocessing claims contradicted by Olympus internal data
Wrongful death and survival actions
State-specific · 35+ documented deaths
Punitive damages
Federal criminal plea + 5 repeat warning letters + Import Alert 89-04 = strongest factual predicate
Personal jurisdiction over the Japanese parent
Four federal and state-court orders have upheld personal jurisdiction over the Tokyo Olympus parent through stream-of-commerce-plus and procedural-waiver theories. PJ over OMSC is no longer an open question for plaintiffs' counsel.
Heise v. Olympus Optical Co.
111 F.R.D. 1 (N.D. Ind. 1986)
PJ defense waived; service on U.S. subsidiary's officer valid for parent.
Lynch v. Olympus Am., Inc.
2019 U.S. Dist. LEXIS 94243 (D. Colo. Jun 5, 2019)
OMSC's renewed 12(b)(2) motion DENIED.
Vaughan v. Olympus Am., Inc.
208 A.3d 66 (Pa. Super. 2019)
Trial court's preliminary objection on PJ REVERSED.
Collett v. Olympus Med. Sys. Corp.
437 F. Supp. 3d 1272 (M.D. Ga. 2020)
OMSC's 12(b)(2) motion DENIED on stream-of-commerce-plus grounds.
Who may have a viable case
Patients (or families of deceased patients) matching the following profile likely have a viable claim. PharmaIntel surfaces this checklist automatically when a caller mentions ERCP, scope-related infection, or any of the listed pathogens.
Statute of limitations · delayed discovery
State-specific 2-to-4-year limitations periods generally apply to products-liability and wrongful-death claims. Most jurisdictions recognize a delayed-discovery doctrine that resets the clock at the date the plaintiff knew or reasonably should have known of the device-causation link. Recent public disclosure events that may extend or toll older claims:
Dec 10, 2018
Federal criminal plea admissions (D.N.J.)
Jun 24, 2025
FDA Import Alert 89-04 (47-58 device models)
Oct 2025
Olympus Worldwide Field Safety Notice (admits IFU inadequate)
Feb 12, 2026
MAJ-1443/1444 valve recall — 89,579 units
PharmaIntel subscribers see the full outbreak registry, every affected facility's live ERCP volume, current settlement benchmarks by venue, and the ability to screen any caller's circumstances against the criteria above in seconds.
Sources for verification
Every factual assertion above is anchored to one or more of the following publicly verifiable primary sources:
Dossier prepared May 2026. This page is a litigation-intelligence overview, not legal advice. Plaintiff viability depends on jurisdiction-specific statutes of limitations, individual medical records, and discovery against the relevant facility. PharmaIntel subscribers get the complete registry with venue-specific guidance.