Olympus Corporation of the Americas
286 federal recalls on file, showing the 122 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Olympus Corporation of the Americas and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-25FDA-DeviceClass IStop using Olympus insufflation unit Model UHI
Olympus Corporation is recalling the High Flow Insufflation Unit (Model UHI) used during abdominal surgery due to a software problem that may cause overpressure events. The device is used to inflate the abdominal cavity and remove smoke during laparoscopic surgery. No injuries have been reported.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-VC411Q-0725 sphincterotome
Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0725) used during endoscopic procedures. Some devices may not have undergone proper thermoforming during manufacturing, which could cause them to deform and lose performance during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-V411M-3025 sphincterotome
Olympus has recalled certain Single Use 3-Lumen Sphincterotomes (Model KD-V411M-3025) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing and could deform or stop working correctly during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V411M-3020
Olympus has recalled certain Single Use 3-Lumen Sphincterotomes (model KD-V411M-3020) used in endoscopic procedures. Some devices may not have undergone proper manufacturing and could deform during use, affecting their ability to perform as intended.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome KD-401Q-0725
Olympus has recalled certain Disposable Triple Lumen Sphincterotomes (model KD-401Q-0725) used in endoscopic procedures. Some devices may not have undergone proper manufacturing steps and could deform or lose performance during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-401Q-0320
Olympus Corporation of the Americas is recalling certain Disposable Triple Lumen Sphincterotomes (model KD-401Q-0320) used in endoscopic procedures. Some devices may not have undergone proper heat treatment and could deform during use, affecting their ability to perform correctly.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-V411M-3030 sphincterotomes
Olympus Corporation is recalling certain single-use 3-lumen sphincterotomes (model KD-V411M-3030) used in endoscopic procedures. Some devices may not have undergone proper thermoforming during manufacturing, which could cause them to deform and fail to work correctly during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-V411M-1530 sphincterotome
Olympus is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-1530) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and lose performance during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V411M-1520
Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-1520) used during endoscopic procedures. Some units may not have been properly heat-formed during manufacturing, which could cause them to deform and stop working as intended.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-401Q-0730 sphincterotomes
Olympus has recalled certain Disposable Triple Lumen Sphincterotome devices (Model KD-401Q-0730) because some units may not have undergone proper manufacturing. These devices could deform during use and may not perform as intended during papillotomy procedures.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-401Q-0720
Olympus Corporation of the Americas is recalling certain Disposable Triple Lumen Sphincterotomes (model KD-401Q-0720) used during endoscopic procedures. Some devices may not have undergone proper manufacturing and could deform during use, which may cause them to lose their intended performance.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-401Q-0330 sphincterotomes
Olympus Corporation has recalled certain Disposable Triple Lumen Sphincterotome devices (model KD-401Q-0330) used in endoscopic procedures. Some devices may not have undergone proper thermoforming, which could cause them to deform and fail to perform as intended during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus KD-411Q-0730 sphincterotome
Olympus has recalled certain Disposable Triple Lumen Sphincterotomes (model KD-411Q-0730) used during endoscopic procedures. Some devices may not have been properly heat-treated during manufacturing, which could cause them to deform and not work as intended during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-411Q-0720
Olympus Corporation of the Americas is recalling certain Disposable Triple Lumen Sphincterotomes (model KD-411Q-0720) used during endoscopy procedures. Some devices may not have undergone proper manufacturing and could deform during use, which would cause them to stop working correctly.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-VC433Q-0730
Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC433Q-0730) used in endoscopic procedures because some units did not undergo proper thermoforming during manufacturing. These devices may deform and lose performance during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-VC433Q-0720
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC433Q-0720) used in endoscopic procedures. Some devices may not have been properly heat-formed during manufacturing, which could cause them to deform and stop working correctly during a procedure.
- 2026-02-11FDA-DeviceClass IICheck Olympus sphincterotome model KD-VC412Q-0215
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC412Q-0215) used in endoscopy procedures. Some devices may not have been properly heat-treated during manufacturing, which could cause them to deform and stop working correctly during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-VC411Q-0330
Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0330) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and not work as intended during use.
- 2026-02-11FDA-DeviceClass IICheck Olympus sphincterotome devices for deformation
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (Model KD-VC411Q-0320) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and stop working properly during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-VC411Q-0730
Olympus Corporation of the Americas is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0730) used in endoscopic procedures. Some devices may not have undergone proper thermoforming during manufacturing, which could cause them to deform and lose their intended performance during use.
- 2026-02-11FDA-DeviceClass IIStop using affected Olympus sphincterotome devices
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0720) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and stop working as intended during medical procedures.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-VC431Q-0730
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC431Q-0730) used in endoscopic procedures. Some devices may not have undergone proper heat treatment during manufacturing, which could cause them to deform and stop working correctly during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V431M-0730
Olympus has recalled certain single-use sphincterotome devices (model KD-V431M-0730) used during endoscopy procedures. Some devices may not have been properly formed during manufacturing and could deform or fail to work as intended during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V431M-0720
Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-V431M-0720) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and stop working correctly during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V411M-0730
Olympus Corporation of the Americas is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-0730) used in endoscopic procedures. Some devices may not have undergone proper thermoforming, which could cause them to deform and not work as intended. No injuries have been reported.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V411M-0725
Olympus is recalling certain batches of its Single Use 3-Lumen Sphincterotome V (model KD-V411M-0725), a surgical tool used during endoscopic procedures. Some devices may not have undergone proper manufacturing and could deform during use, affecting their performance. No injuries have been reported.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome model KD-V411M-0720
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-0720) used in endoscopy procedures. Some devices may not have been properly heat-treated during manufacturing, which could cause them to deform and stop working as intended during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome devices
Some Olympus sphincterotome devices (model KD-V411M-0330) may not have been properly processed during manufacturing. Devices that skipped a key heating step could deform and fail to work correctly during medical procedures.
- 2026-02-11FDA-DeviceClass IIStop using Olympus sphincterotome KD-431Q-0720
Olympus has recalled certain Disposable Triple Lumen Sphincterotomes (model KD-431Q-0720) used in endoscopic procedures because some devices may not have been properly heat-treated during manufacturing. Affected devices could deform and lose their intended performance during use.
- 2026-02-11FDA-DeviceClass IIStop using Olympus Sphincterotome V model KD-VC431Q-0720
Olympus has recalled certain Single Use Sphincterotome V devices (model KD-VC431Q-0720) used in endoscopic procedures. Some devices in this batch may not have been properly heat-formed during manufacturing, which could cause them to deform and stop working correctly during use. No injuries have been reported.
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