medical MODERATE Updated 2026-07-15

Olympus Corporation of the Americas recalls Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Us

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Recalled Product

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid

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Hazard / Issue

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI: 04953170441271, Lot Numbers: H2530 or later

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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