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Aomori Olympus Co., Ltd.

Country not established

Devices
7
FDA recalls
1132 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Aomori Olympus Co., Ltd. makes

Aomori Olympus Co., Ltd. manufactures ultrasonic surgical systems, including the Sonosurg and Olympus ultrasonic surgical systems, which use high-frequency sound waves for tissue dissection and coagulation. The company also produces endoscopic tools like the mucus collection probe (models BC-401C and BC-402C) and the Sonosurg trocar for minimally invasive procedures. Additionally, it supplies pancreatic drainage tubes and single-use 3-lumen balloon catheters (models B-230Q-A and B-230Q-B) for biliary and pancreatic interventions.

These devices are classified under FDA Class II and Class U, with records supported by 510(k) submissions. The company’s products are listed in the U.S. FDA registry, adhering to regulatory requirements for surgical instruments, endoscopic accessories, and drainage catheters. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue7

Newest first, rows 1-7 of 7

FDA recalls113

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 113 recalls initiated by Aomori Olympus Co., Ltd., the earliest on 2021-01-04 and the most recent on 2023-07-27. By recorded status: 2 ongoing and 111 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 111
  • 2022 0
  • 2023 2
  • 2024 0
  • 2025 0
  • 2026 0

Showing the 10 most recent of 113 recalls.

  • 2023

    • 27 Jul 2023 Z-2522-2023 Class II Ongoing The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 Distribution: US Nationwide distribution. Submission number: K984358
    • 27 Jul 2023 Z-2523-2023 Class II Ongoing The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 Distribution: US Nationwide distribution. Submission number: K984358

  • 2021

    • 4 Jan 2021 Z-0961-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K962925
    • 4 Jan 2021 Z-0962-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K962925
    • 4 Jan 2021 Z-0963-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K962925
    • 4 Jan 2021 Z-0964-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K962925
    • 4 Jan 2021 Z-0965-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K962925
    • 4 Jan 2021 Z-0966-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K091495
    • 4 Jan 2021 Z-0967-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K091495
    • 4 Jan 2021 Z-0968-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K091495
Show the 25 most recent of 113 recalls

  • 2021

    • 4 Jan 2021 Z-0969-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K950729
    • 4 Jan 2021 Z-0970-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K060243
    • 4 Jan 2021 Z-0971-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K060243
    • 4 Jan 2021 Z-0972-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K060243
    • 4 Jan 2021 Z-0973-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K060243
    • 4 Jan 2021 Z-0974-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K092309
    • 4 Jan 2021 Z-0975-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K092309
    • 4 Jan 2021 Z-0976-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K092309
    • 4 Jan 2021 Z-0977-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K092309
    • 4 Jan 2021 Z-0978-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K092309
    • 4 Jan 2021 Z-0979-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K092309
    • 4 Jan 2021 Z-0980-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K092309
    • 4 Jan 2021 Z-0981-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K092309
    • 4 Jan 2021 Z-0982-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K171158
    • 4 Jan 2021 Z-0983-2021 Class II Terminated Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. Distribution: US Nationwide distribution. Submission number: K171158

Frequently asked questions

How many devices does Aomori Olympus Co., Ltd. have in the registry?

The registry currently lists 7 devices for Aomori Olympus Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Aomori Olympus Co., Ltd.'s devices?

Among its 7 most recently registered devices, Aomori Olympus Co., Ltd. has devices listed in FDA 510(k) (7 devices).

What risk classes do Aomori Olympus Co., Ltd.'s devices fall under?

Among its 7 most recently registered devices, the classes recorded for Aomori Olympus Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Aomori Olympus Co., Ltd.?

FDA recall records list 113 recalls initiated by Aomori Olympus Co., Ltd., the most recent initiated on 27 Jul 2023. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Aomori Olympus Co., Ltd. in the registry?

The most recently registered devices listed for Aomori Olympus Co., Ltd. include SONOSURG ULTRASONIC SURGICAL SYSTEM, MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C, OLYMPUS ULTRASONIC SURGICAL SYSTEM and PANCREATIC DRAINAGE TUBE.

Generated automatically from registry data and not verified by a human reviewer.