Updated August 2026 by Matthew T. Marin, Esq. (Super Lawyers 2014–2024, member of the American Association for Justice, and Mass Torts Made Perfect (MTMP) speaker) — a personal-injury and mass-tort trial attorney.

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Olympus Scope — Infection Claims

Hospitalized With an Infection After a Scope Procedure?

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Updated August 2026 by Matthew T. Marin, Esq. (Super Lawyers 2014–2024, member of the American Association for Justice, and Mass Torts Made Perfect (MTMP) speaker) — a personal-injury and mass-tort trial attorney.

Matthew T. Marin, J.D. — Admitted in Rhode Island, South Carolina, Connecticut, and Massachusetts

Stefanie A. Murphy, J.D. — Admitted in Rhode Island, Connecticut, and Massachusetts

In June 2025, the FDA issued Import Alert 89-04 blocking 58 Olympus medical device models from entering the United States, citing ongoing violations of FDA Quality System Regulations at Olympus’s Aizu, Japan manufacturing facility. This is one of the most sweeping FDA enforcement actions against any medical device manufacturer in recent history.

Regulatory Record Summary

Regulatory Body

U.S. Food and Drug Administration

Action Date

June 24, 2025

Action Type

FDA Import Alert 89-04

Key Outcome

58 device models blocked from US entry / 21 CFR Part 820 violations

What Is FDA Import Alert 89-04 and What Does It Do?

Import Alert 89-04 was issued by the FDA on June 24, 2025. An FDA import alert is a regulatory tool that authorizes FDA field personnel to detain shipments of a manufacturer’s products at the US border without physical examination — based on prior documented violations of FDA regulations. Unlike a product recall, which typically targets specific device models, Import Alert 89-04 covers 58 Olympus device models manufactured at the Aizu facility, Japan.

(Source: FDA Import Alert 89-04, accessdata.fda.gov.) The legal basis for Import Alert 89-04 is violation of 21 CFR Part 820, the FDA’s Quality System Regulation. Part 820 governs how medical devices are designed, manufactured, tested, and quality-controlled. A Part 820 violation finding at Olympus’s primary manufacturing facility means the FDA determined that the quality management system governing Olympus’s entire device production process was deficient — not just one duodenoscope, not one product line, but the underlying quality infrastructure itself. 58 device models is an extraordinarily sweeping scope.

For context: a typical FDA import alert against a medical device manufacturer might target one or a small number of specific product types. 58 device models covering effectively the full Olympus product range from the Aizu facility reflects the FDA’s assessment that the quality system failures there are pervasive — not isolated. The FDA reviewed Olympus’s complete import shipment records before issuing this alert. (Source: van der Ploeg K et al., Gut, 2024, PMID 38182137.)

What Is the Full Enforcement History That Led to Import Alert 89-04?

Import Alert 89-04 did not emerge from a single inspection finding. It is the latest — and most aggressive — action in a decade-long pattern of FDA enforcement against Olympus. The timeline below documents every major regulatory action leading to and following the June 2025 import alert, confirmed from primary sources.

February 19, 2015

FDA — Safety Communication

FDA Safety Communication acknowledged manufacturer cleaning instructions for ERCP duodenoscopes “may be inadequate.” At this date, 75 MDRs involving approximately 135 patients had already been filed between January 2013 and December 2014. This communication came more than two years after Olympus first received hospital notifications of CRE outbreaks.

Source: FDA Safety Communication, February 19, 2015

March 2018

FDA — Warning Letter MARCS-CMS 546986

More than two years after the FDA issued a mandatory Section 522 postmarket surveillance order, Olympus had established zero surveillance sites. The warning letter documented this defiance while Olympus was simultaneously under criminal investigation for failing to file FDA-required adverse-event reports.

Source: FDA Warning Letter MARCS-CMS 546986, March 2018

December 10, 2018

DOJ — Criminal Guilty Plea

Olympus Medical Systems Corporation and former Vice President Hisao Yabe pleaded guilty to three counts of distributing misbranded medical devices (21 U.S.C. § 331(k)). $85 million in penalties. Admitted failing to file FDA-required adverse-event reports. Case No. 2:18-cr-00727-SRC, D.N.J.

Source: DOJ press release, December 10, 2018

March 2023

FDA — Warning Letter MARCS-CMS 654013

Olympus failed to investigate cracking of the MAJ-2315 distal end cover for approximately two years after becoming aware of the defect. Same pattern: identify a problem, take no corrective action, face regulatory consequences. This is the second major warning letter in five years targeting the same fundamental failure mode.

Source: FDA Warning Letter MARCS-CMS 654013, March 2023

December 18, 2024

FDA — Class I Recall Z-0905-2025 (MAJ-891)

FDA Class I Recall of the MAJ-891 Forceps/Irrigation Plug. 30,140 units in US commerce. MAUDE adverse event reports: 120+ reported injuries, 1 confirmed death. Class I = risk of serious adverse health consequences or death. FDA-determined cause: labeling design.

Source: FDA Recall Z-0905-2025, December 18, 2024

June 24, 2025

FDA — Import Alert 89-04 (Primary Event)

58 Olympus device models from the Aizu, Japan manufacturing facility blocked from US entry. Legal basis: 21 CFR Part 820 Quality System Regulation noncompliance. Customs detention authorized without physical examination. This is the culmination of a decade of escalating FDA enforcement — each prior action failing to produce systemic compliance, until the FDA employed one of its most powerful import enforcement tools.

Source: FDA Import Alert 89-04, June 24, 2025, accessdata.fda.gov

October 14–17, 2025

Olympus — Urgent Field Safety Notice

Four months after the import alert, Olympus admitted that prior reprocessing protocols for TJF-Q190V, TJF-Q290V, and TJF-Q170V duodenoscopes were insufficient; that naked-eye inspection was insufficient; and that 10X magnification tools were now required to detect contamination invisible to the naked eye. 2 confirmed deaths and 5 serious injuries linked to these scopes at the time of the notice. The UFSN corroborates the systemic quality failures documented in the import alert.

Source: Olympus Urgent Field Safety Notice, October 14–17, 2025 (on file)

March 2026

Health Canada — Recall

Health Canada recalled Olympus MAJ-1443 and MAJ-1444 valve accessories. The most recent global regulatory action as of this sprint’s launch, confirming that Olympus device safety issues are not limited to US regulatory jurisdiction.

Source: Health Canada Recall, March 2026 (on file)

What Does Import Alert 89-04 Mean for Patient Claims?

Why FDA Import Alert 89-04 Matters for Patient Claims

Import Alert 89-04 is significant in product liability litigation not because of what it requires hospitals to do — existing inventory is unaffected — but because of what it confirms: that as of June 24, 2025, the FDA determined Olympus’s quality controls were so deficient that the agency invoked one of its most aggressive enforcement tools against the company’s entire manufacturing output from Aizu. For patients whose procedures occurred at any point in the claims period, the import alert is evidence of systemic and continuing quality failures. (Source: Ross AS et al., Gastrointest Endosc., 2015, PMID 26092616.)

  1. The import alert establishes systemic quality system failure. A Part 820 violation finding at the primary manufacturing facility means the FDA found that the quality controls governing everything Olympus manufactures at Aizu were deficient. In product liability litigation, this is a much stronger predicate for punitive damages than an isolated device defect. It establishes that the failure was organizational — embedded in the quality management infrastructure — not accidental or limited to one product line.
  2. The import alert corroborates the decade-long enforcement pattern. The import alert is the fifth major FDA action in ten years against the same manufacturer. Each prior action — 2015 Safety Communication, 2018 warning letter, 2018 criminal guilty plea, 2023 warning letter, 2024 Class I recall — failed to produce demonstrated systemic compliance. The FDA’s escalation to import alert is itself evidence that Olympus’s compliance failures are persistent and resistant to correction.
  3. Patients who had 2025–2026 procedures have additional evidentiary support. Patients who developed infections after ERCP or other scope procedures in 2025 or 2026 using Olympus devices may be able to reference the import alert’s issuance as regulatory confirmation of Olympus’s quality failures as of the time of their procedures. The alert does not retroactively affect devices already in hospital supply chains, but it confirms the FDA’s assessment of Olympus’s quality management status at that time.

What Should Patients Who Had Procedures in 2025 or 2026 Know?

The import alert’s issuance in June 2025 does not retroactively affect procedures performed before that date — it confirms the FDA’s view of Olympus’s quality problems as of June 2025. US hospitals that had existing Olympus device inventory before June 2025 could continue using those devices; the import alert blocks new shipments from the Aizu facility pending compliance with 21 CFR Part 820. (Source: FDA Import Alert 89-04, June 24, 2025.) Patients who developed infections after scope procedures in 2025 or 2026 should preserve all procedure records, including scope model and serial number if available from hospital records; request medical records documenting the infection diagnosis, hospitalization, and antibiotic treatment; note the procedure date and the date the infection was first diagnosed; and contact a mass tort attorney to discuss the situation.

The October 2025 Urgent Field Safety Notice — issued four months after the import alert — confirmed that prior protocols for TJF-Q190V, TJF-Q290V, and TJF-Q170V duodenoscopes were inadequate and that 2 deaths and 5 serious injuries had been linked to these devices. The combined regulatory record — import alert (June 2025) followed by protocol inadequacy admission (October 2025) — means that patients who had scope procedures in mid-to-late 2025 have both an active quality system violation finding and an affirmative admission of protocol inadequacy applying to their procedures.

(Source: Bomman S et al., Clinical Endoscopy, January 2022, PMC8831410; Senate HELP Committee, January 13, 2016.)

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Related Resources

Frequently Asked Questions About FDA Import Alert 89-04

Q1: What is FDA Import Alert 89-04? ▼

FDA Import Alert 89-04, issued June 24, 2025, authorizes FDA field personnel to detain shipments of Olympus medical devices from the Aizu, Japan manufacturing facility at the US border without physical examination. The basis is ongoing violations of 21 CFR Part 820 — the Quality System Regulation governing device design, manufacturing, and quality control. 58 device models are affected.

This means effectively the entire Olympus medical device product line from the Aizu facility is subject to customs detention when shipped to the US. The import alert reflects the FDA’s determination that Olympus’s quality problems at Aizu are systemic and pervasive — not limited to any specific device or product category.

Q2: How many Olympus device models were blocked? ▼

58 Olympus device models from the Aizu, Japan manufacturing facility are subject to detention under Import Alert 89-04. Most FDA import alerts against medical device manufacturers target one or a small number of specific product types. 58 device models is one of the most sweeping import actions against any medical device manufacturer in FDA history.

58 device models means the FDA’s quality concerns at the Aizu facility extend across Olympus’s entire product range manufactured there — not just duodenoscopes or endoscopes. This reflects the FDA’s finding that the quality management system itself is deficient, not that any particular device model failed a particular test.

Q3: What does 21 CFR Part 820 mean and why does it matter? ▼

21 CFR Part 820 is the FDA’s Quality System Regulation — the comprehensive federal standard governing how medical devices are designed, manufactured, tested, and quality-controlled throughout their production lifecycle. A Part 820 violation at Olympus’s primary manufacturing facility means the FDA found the quality management system deficient at the facility level — not just one product.

This is not a finding about one defective device or one failed test. It is a finding about the quality infrastructure governing everything manufactured at the Aizu facility. In product liability litigation, a systemic quality system failure is a much stronger predicate for punitive damages than an isolated manufacturing defect.

Q4: Does the import alert mean Olympus devices are banned in the US? ▼

No — existing inventory already in US hospitals and surgical centers is unaffected by the import alert. The alert blocks new shipments from the Aizu facility from entering the US pending demonstrated compliance with 21 CFR Part 820. It does not mandate a recall of devices already in use.

However, the import alert is significant as regulatory evidence because it confirms that the FDA — as of June 2025 — had determined Olympus’s quality controls were so deficient that its products required customs detention to protect US patients. This determination corroborates the systemic quality failure argument that applies across the entire claims period.

Q5: Can I use the import alert as evidence in my Olympus scope lawsuit? ▼

The import alert may be relevant regulatory evidence in product liability litigation. It establishes that the FDA — as of June 2025 — found Olympus’s quality controls at the Aizu facility sufficiently deficient to warrant import detention of the company’s full product range from that facility.

This corroborates a systemic quality control failure argument that applies across the claims period. The import alert does not create a new cause of action by itself, but it is additional documentary evidence of Olympus’s regulatory relationship with the FDA. Consult Marin & Murphy to discuss how this regulatory action applies to the specific facts of your case.

Q6: What came before the import alert in Olympus’s FDA enforcement history? ▼

The import alert is the fifth major FDA enforcement action in a ten-year pattern: February 2015 Safety Communication; March 2018 Warning Letter MARCS-CMS 546986 (zero surveillance sites); December 2018 DOJ guilty plea ($85 million); March 2023 Warning Letter MARCS-CMS 654013 (cracked components ignored); December 2024 Class I Recall (MAJ-891, 30,140 units).

The June 2025 Import Alert, plus the October 2025 UFSN admission of insufficient protocols, complete a decade of escalating enforcement against the same manufacturer at the same manufacturing facility. Each prior action failed to produce demonstrated systemic compliance. The FDA’s escalation to import alert reflects its conclusion that prior enforcement tools had been insufficient to compel compliance.

Sources (11 primary sources)
  1. FDA Import Alert 89-04, June 24, 2025. accessdata.fda.gov.
  2. 21 CFR Part 820 — FDA Quality System Regulation for medical devices.
  3. FDA Safety Communication, February 19, 2015. fda.gov.
  4. FDA Warning Letter MARCS-CMS 546986, March 2018. fda.gov.
  5. FDA Warning Letter MARCS-CMS 654013, March 2023. fda.gov.
  6. FDA Recall Z-0905-2025 (MAJ-891), December 18, 2024. accessdata.fda.gov.
  7. DOJ press release, December 10, 2018. justice.gov. Case No. 2:18-cr-00727-SRC, U.S. District Court for the District of New Jersey.
  8. Olympus Urgent Field Safety Notice, October 14–17, 2025. Retrieved via Estonian RAVIMIAMEET archive; confirmed by HPRA Ireland. (on file)
  9. Health Canada Recall (MAJ-1443 and MAJ-1444), March 2026. (on file)
  10. Ross AS, Baliga C, Verma P, Duchin J, Gluck M. Gastrointest Endosc. 2015;82(3):477–83. PMID 26092616.
  11. van der Ploeg K et al. Gut. 2024;73(4):613–621. PMID 38182137. DOI: 10.1136/gutjnl-2023-330355.

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