The Recall Desk

Manufacturer

Olympus Corporation of the Americas

332 recalls in our database name Olympus Corporation of the Americas as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 332

  • HighFDA (Devices)·Z-1438-2026·2026-03-04

    Olympus Resection Sheath recalled for ceramic tip fracture

    Olympus is recalling Resection Sheath models A22014A and A22014T, used in urological endoscopy, after receiving complaints of ceramic tip breaking.

    Product
    Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2026·2026-03-04

    Olympus Resection Sheath Recalled Due to Ceramic Tip Breaking

    Olympus Corporation is recalling the Resection Sheath Model A22041T due to complaints that the ceramic tip breaks. The device is used for urologic surgical procedures.

    Product
    Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2026·2026-03-04

    Olympus Resection Sheath Recalled for Ceramic Tip Breakage

    Olympus is recalling 118 Resection Sheaths (Model A22043A) distributed nationwide due to complaints of ceramic tip breakage during urologic procedures.

    Product
    Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2026·2026-03-04

    Olympus Resection Sheath ceramic tip may break during use

    Olympus is recalling Resection Sheath Model A2666 due to reports that the ceramic tip can break during urologic surgical procedures. The company has received complaints about this device failure.

    Product
    Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2026·2026-03-04

    Olympus Resection Sheath Recalled Due to Ceramic Tip Fracture Risk

    Olympus Corporation of the Americas is recalling the Olympus Resection Sheath (Model A22042T) due to reports that the ceramic tip can break. The defect affects 1,634 units distributed nationwide.

    Product
    Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2026·2026-03-04

    Olympus Inner Sheath Model A2660 Recall Due to Ceramic Tip Fracture

    Olympus Corporation recalls the Inner Sheath Model A2660 used in urological endoscopic procedures due to complaints that the ceramic tip can break during use. No injuries have been reported.

    Product
    Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1353-2026·2026-02-25

    Olympus High Flow Insufflation Unit recalled for overpressure software defect

    Olympus Corporation recalls 744 High Flow Insufflation Units (Model UHI-2) nationwide due to a software algorithm issue that may cause overpressure events during laparoscopic surgery.

    Product
    Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1354-2026·2026-02-25

    Olympus Insufflation Unit Recalled for Software Overpressure Risk

    Olympus is recalling 485 High Flow Insufflation Units nationwide due to a software algorithm defect that may cause overpressure during laparoscopic surgery.

    Product
    Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1352-2026·2026-02-25

    Olympus High Flow Insufflation Unit software defect may cause overpressure

    Olympus Corporation recalled 18 High Flow Insufflation Units nationwide due to a software algorithm issue that may lead to overpressure events during laparoscopic surgery.

    Product
    Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2026·2026-02-25

    Olympus Thunderbeat Device Recalled Due to Adverse Events

    Olympus Corporation of the Americas is recalling the Olympus Thunderbeat 5 mm, 35 cm device due to continued adverse event reports. Approximately 88,268 units are affected across worldwide distribution.

    Product
    Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2026·2026-02-25

    Olympus Thunderbeat Surgical Instrument Recalled Due to Adverse Events

    Olympus is recalling all lots of the Thunderbeat ultrasonic surgical instrument worldwide due to continued reports of adverse events.

    Product
    Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recalled Due to Adverse Event Reports

    Olympus has initiated a removal of Thunderbeat 5 mm surgical devices following continued reports of adverse events. The affected devices were distributed worldwide, including throughout the United States.

    Product
    Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2026·2026-02-25

    Olympus Thunderbeat Surgical Instrument Recalled for Adverse Events

    Olympus Corporation of the Americas is recalling the Olympus Thunderbeat surgical instrument due to continued reports of adverse events. Approximately 52 units were distributed worldwide.

    Product
    Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recalled for Reported Adverse Events

    Olympus Corporation is recalling the Thunderbeat 5 mm surgical device due to continued reports of adverse events. The device has been distributed worldwide, including throughout the United States.

    Product
    Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2026·2026-02-25

    Olympus Thunderbeat surgical instrument recalled due to adverse events

    Olympus Corporation is recalling 9,542 Thunderbeat surgical instruments worldwide due to continued reports of adverse events. Users should contact the manufacturer for instructions.

    Product
    Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2026·2026-02-25

    FDA Recalls Olympus Thunderbeat Surgical Device for Adverse Events

    Olympus is recalling the Thunderbeat surgical device model TB-0520IC due to continued reports of adverse events. The recall affects 140 units distributed worldwide.

    Product
    Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recalled for Adverse Events

    Olympus Corporation is recalling the Olympus Thunderbeat 5 mm surgical device due to continued reports of adverse events. The device was distributed worldwide including the United States.

    Product
    Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2026·2026-02-25

    Olympus Thunderbeat Surgical Instrument Recalled Due to Adverse Events

    Olympus Corporation of the Americas is recalling 3,381 units of its Olympus Thunderbeat surgical instrument worldwide due to continued reports of adverse events.

    Product
    Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Removal Due to Adverse Events

    Olympus Corporation is removing Thunderbeat surgical instruments worldwide due to continued reports of adverse events. The 5 mm, 45 cm pistol grip devices affected include all manufacturing lots.

    Product
    Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2026·2026-02-25

    FDA Recalls Olympus Thunderbeat 5mm Surgical Instruments Due to Adverse Events

    Olympus Corporation is recalling 4,181 units of the Olympus Thunderbeat 5mm surgical device due to continued reports of adverse events. The device was distributed across the U.S., Brazil, Canada, Germany, Mexico, and Japan.

    Product
    Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2026·2026-02-25

    Olympus Thunderbeat Surgical Instrument Recall Due to Adverse Events

    Olympus is recalling approximately 1,538 Thunderbeat surgical instruments due to continued reports of adverse events. Affected devices are being removed from distribution.

    Product
    Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1297-2026·2026-02-11

    Olympus Sphincterotome Recall Due to Potential Deformation and Performance Loss

    Olympus is recalling 1,474 units of the Single Use 3-Lumen Sphincterotome V distributed outside the US. Some devices may not have undergone proper thermoforming, which could cause deformation and performance loss.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2026·2026-02-11

    Olympus Single Use 3-Lumen Sphincterotome V Recalled Due to Deformation Risk

    Olympus Corporation is recalling the Single Use 3-Lumen Sphincterotome V surgical device due to a manufacturing defect where some devices may not have undergone proper thermoforming, potentially causing deformation and performance loss during surgical procedures.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2026·2026-02-11

    Olympus Sphincterotome Devices Recalled for Potential Deformation and Performance Loss

    Olympus Corporation is recalling Single Use 3-Lumen Sphincterotome V devices (Model KD-VC411Q-0320) because some units did not undergo proper thermoforming and could deform or lose performance during use.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2026·2026-02-11

    Olympus Sphincterotome V Recalled Due to Potential Device Deformation

    Olympus recalls single-use sphincterotomes that may deform and lose performance if not properly thermoformed during manufacturing. No injuries have been reported.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide