Olympus Corporation’s FDA Enforcement Record — Warning Letters, Recalls, and the 2025 Import Block

FDA — Safety Communication

The FDA issued its first public acknowledgment that manufacturer cleaning instructions for ERCP duodenoscopes “may be inadequate to prevent the transmission of infection.” At the time of this communication, 75 MDRs involving approximately 135 patients had already been filed with the FDA between January 2013 and December 2014. The Safety Communication came more than two years after Olympus first received hospital notifications of CRE outbreaks linked to its scopes.

Source: FDA Safety Communication, February 19, 2015, fda.gov

Senate HELP Committee — “Preventable Tragedies” Report

The Senate HELP Committee published “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients,” documenting at least 250 patients worldwide, across all three duodenoscope manufacturers, affected by duodenoscope-related infections and identifying this figure as likely a significant undercount. The report documented that Olympus’s December 2012 MDR about the UPMC outbreak appeared never to have been properly entered into the FDA’s adverse event database.

Source: Senate HELP Committee, January 13, 2016

FDA — Warning Letter MARCS-CMS 546986

Following the February 2015 Safety Communication, the FDA ordered Olympus to conduct mandatory postmarket surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360l). The order required Olympus to establish surveillance sites at hospitals actively using duodenoscopes and collect systematic contamination rate, infection transmission, and patient outcome data. More than two years later, the FDA documented that Olympus had established zero surveillance sites. Not one hospital. Not one data point. This surveillance non-compliance occurred simultaneously with the reporting failure that resulted in an $85 million criminal guilty plea in December 2018.

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

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)). Case No. 2:18-cr-00727-SRC, U.S. District Court for the District of New Jersey. Combined penalties: $85 million. Olympus admitted failing to file FDA-required adverse-event reports during the period encompassing all four named hospital outbreaks. The guilty plea occurred while the FDA March 2018 warning letter for surveillance non-compliance was still pending remediation.

Source: DOJ press release, December 10, 2018, justice.gov

FDA — Warning Letter MARCS-CMS 654013

The FDA issued a second major warning letter addressing Olympus’s failure to investigate cracking of the MAJ-2315 distal end cover — a component of the duodenoscope distal tip assembly — for approximately two years after becoming aware of the defect. The same pattern: Olympus identifies a device problem, takes no corrective action, and eventually faces regulatory consequences. The MAJ-2315 cracking issue is distinct from the elevator mechanism contamination problem but reflects the same corporate response to device safety data. (Source: van der Ploeg et al., Gut, 2024, PMID 38182137.)

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

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

FDA Class I Recall Z-0905-2025 was initiated for the MAJ-891 Forceps/Irrigation Plug — an Olympus accessory used during ERCP procedures. 30,140 units were distributed in the United States. Class I is the most serious FDA recall classification, reserved for devices where there is a reasonable probability that use will cause serious adverse health consequences or death. FDA-determined cause: labeling design. MAUDE adverse event reports: 120+ reported injuries and 1 confirmed death.

Source: FDA Recall Z-0905-2025, December 18, 2024, accessdata.fda.gov

FDA — Import Alert 89-04

FDA Import Alert 89-04 blocked 58 Olympus device models from entering the United States from the Aizu, Japan manufacturing facility. Legal basis: 21 CFR Part 820 Quality System Regulation noncompliance. An import alert authorizes customs detention of a company’s products without physical examination — based on prior documented violations. 58 device models means effectively the entire Olympus medical device product line from the Aizu facility was subject to detention at the US border.

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

Olympus — Urgent Field Safety Notice

Olympus issued a worldwide Urgent Field Safety Notice admitting: (1) prior reprocessing materials and instructions for TJF-Q190V, TJF-Q290V, and TJF-Q170V duodenoscopes required updates because prior protocols were inadequate; (2) naked-eye visual inspection was declared insufficient; (3) 10X magnification tools — which hospitals had never previously been told to use — were now required to detect damage and contamination invisible to the naked eye; (4) 2 confirmed deaths and 5 serious injuries were linked to these scopes at the time of the notice. Ten years after the February 2015 Safety Communication, Olympus admitted its protocols had been inadequate throughout the entire claims period.

Source: Olympus Urgent Field Safety Notice, October 14–17, 2025 (on file; retrieved via Estonian RAVIMIAMEET archive; confirmed by HPRA Ireland)

Health Canada — Recall

Health Canada recalled Olympus MAJ-1443 and MAJ-1444 valve accessories — the most recent global regulatory action against Olympus as of this sprint’s launch. The Health Canada recall confirms that Olympus’s device safety issues are not limited to US regulatory jurisdiction but represent a global pattern of product failures requiring multi-agency response.

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