Olympus
93 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Olympus and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-V411M-3030 sphincterotomes
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-V411M-1530 sphincterotome
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V411M-1520
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-401Q-0730 sphincterotomes
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-401Q-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-401Q-0330 sphincterotomes
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-411Q-0730 sphincterotome
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-411Q-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-VC433Q-0730
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-VC433Q-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IICheck Olympus sphincterotome model KD-VC412Q-0215
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-VC411Q-0330
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IICheck Olympus sphincterotome devices for deformation
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-VC411Q-0730
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using affected Olympus sphincterotome devices
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-VC431Q-0730
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V431M-0730
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V431M-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V411M-0730
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V411M-0725
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V411M-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome devices
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome KD-431Q-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus Sphincterotome V model KD-VC431Q-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus CleverCut sphincterotome devices
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus electrosurgical knife KD-645L
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-640L electrosurgical knives
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
- 2025-12-03FDA-DeviceClass IIBrand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
- 2025-12-03FDA-DeviceClass IBrand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
- 2025-11-26FDA-DeviceClass IIBrand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
Get notified about new Olympus recalls
Free weekly digest. We email when a new federal recall affects Olympus or anything else in your household.
Get the Sunday Brief