FDA Issues Class I Recall for Olympus Endoscope Accessory

The FDA has classified Olympus’ recall of the MAJ-891 forceps/irrigation plug as a Class I recall—the most serious designation—following reports of 120 injuries and one death linked to improper reprocessing of the device. Though Olympus discontinued the accessory in the U.S. in 2022, healthcare providers may still be using it, prompting the company to recommend alternative devices where possible. The recall affects over 30,000 units, and the FDA warns that improper cleaning and disassembly could lead to infections, sepsis, or death.

While Olympus has faced previous recalls and regulatory scrutiny over endoscope safety, the MAJ-891 issue underscores broader concerns regarding reusable medical device contamination. The company advises users to either switch to alternative equipment or meticulously follow reprocessing guidelines to minimize infection risks. With safety concerns driving a shift toward single-use endoscopes, Olympus continues to navigate regulatory pressures and market shifts in endoscopic technology.