OlympusRecalls & reported problems across all models

We found 27 models of Olympus by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 518 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2020 and Sep 30, 2026 — classified as 67 injuries, 451 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (86 reports).

21 FDA recall records name at least one of these models by its device identifier, 21 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Olympus recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 18, 2026Open, Classified

   Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

   Z-3035-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. Feb 25, 2026Open, Classified

   Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

   Z-1640-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Feb 25, 2026Open, Classified

   Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

   Z-1639-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. Feb 25, 2026Open, Classified

   Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

   Z-1638-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

5. Jul 1, 2024Open, Classified

   Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

   Z-2542-2024 · Root cause: Package design/selection · Recall details · FDA record ↗

6. Jul 1, 2024Open, Classified

   Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

   Z-2541-2024 · Root cause: Package design/selection · Recall details · FDA record ↗

7. Mar 7, 2024Open, Classified

   Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

   Z-1701-2024 · Root cause: Process control · Recall details · FDA record ↗

8. Mar 7, 2024Open, Classified

   Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

   Z-1700-2024 · Root cause: Process control · Recall details · FDA record ↗

9. Mar 7, 2024Open, Classified

   Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

   Z-1699-2024 · Root cause: Process control · Recall details · FDA record ↗

10. Dec 15, 2023Open, Classified

    The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

    Z-1167-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. Nov 10, 2023Open, Classified

    Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

    Z-0941-2024 · Root cause: Process control · Recall details · FDA record ↗

12. Nov 10, 2023Open, Classified

    Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

    Z-0939-2024 · Root cause: Process control · Recall details · FDA record ↗

13. Nov 10, 2023Open, Classified

    Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

    Z-0938-2024 · Root cause: Process control · Recall details · FDA record ↗

14. Nov 10, 2023Open, Classified

    Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

    Z-0937-2024 · Root cause: Process control · Recall details · FDA record ↗

15. Nov 10, 2023Open, Classified

    Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

    Z-0936-2024 · Root cause: Process control · Recall details · FDA record ↗

16. Nov 10, 2023Open, Classified

    Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

    Z-0935-2024 · Root cause: Process control · Recall details · FDA record ↗

17. Nov 10, 2023Open, Classified

    Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

    Z-0934-2024 · Root cause: Process control · Recall details · FDA record ↗

18. Nov 10, 2023Open, Classified

    Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

    Z-0933-2024 · Root cause: Process control · Recall details · FDA record ↗

19. Aug 12, 2022Open, Classified

    An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

    Z-1815-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

20. Aug 12, 2022Open, Classified

    An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

    Z-1814-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

21. Aug 12, 2022Open, Classified

    An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

    Z-1813-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Olympus problems

Olympus models

27 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Olympus PS-0537CJDA

  Electrosurgical, cutting & coagulation & accessories
  2 recalls184 reports
• Olympus PS-0523CJDA

  Electrosurgical, cutting & coagulation & accessories
  3 recalls90 reports
• Olympus PK-CF0533

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  2 recalls67 reports
• OLYMPUS 3006

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  2 recalls16 reports
• Olympus BD-400P-2080

  Dilator, esophageal
  1 recall60 reports
• Olympus PS-0544CJDA

  Electrosurgical, cutting & coagulation & accessories
  2 recalls10 reports
• OLYMPUS 3005

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  2 recalls6 reports
• Olympus BD-400P-1580

  Dilator, esophageal
  2 recalls4 reports
• Olympus BD-410X-1355

  Dilator, esophageal
  1 recall5 reports
• Olympus BD-400P-1080

  Dilator, esophageal
  1 recall3 reports
• Olympus BD-400P-1380

  Dilator, esophageal
  1 recall3 reports
• Olympus BD-400P-0880

  Dilator, esophageal
  1 recall2 reports
• Olympus BD-410X-0855

  Dilator, esophageal
  1 recall0 reports
• Olympus BD-400P-1880

  Dilator, esophageal
  20 reports
• OLYMPUS GWH3505R

  STYLET, URETERAL
  16 reports
• OLYMPUS NT4F19115

  DISLODGER, STONE, FLEXIBLE
  6 reports
• OLYMPUS GWH3505RA

  STYLET, URETERAL
  5 reports
• OLYMPUS NT4W18115

  DISLODGER, STONE, FLEXIBLE
  4 reports
• OLYMPUS GWH3805R

  STYLET, URETERAL
  4 reports
• OLYMPUS 3700

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  3 reports
• OLYMPUS NT4W22115

  DISLODGER, STONE, FLEXIBLE
  2 reports
• Olympus PS-0537CJSA

  Electrosurgical, Cutting & Coagulation & Accessories
  2 reports
• Olympus PS-0537SJDA

  Electrosurgical, Cutting & Coagulation & Accessories
  2 reports
• OLYMPUS NTCP22115

  DISLODGER, STONE, FLEXIBLE
  1 report
• OLYMPUS NT4W30115

  DISLODGER, STONE, FLEXIBLE
  1 report
• Olympus SPL-PR376

  Lithotriptor, Ultrasonic
  1 report
• Olympus PS-0544CJSA

  Electrosurgical, Cutting & Coagulation & Accessories
  1 report

Recent Olympus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Contamination /Decontamination Problem

  The customer reported that there was a black stain adhered to the handle section involving an Olympus Powerseal. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948840 ↗
• MalfunctionSep 29, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935130 ↗
• MalfunctionSep 28, 2026Energy Output Problem

  The customer reported Energy Output Problem involving an Olympus Powerseal. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922435 ↗
• MalfunctionSep 28, 2026Break

  The customer reported tip breakage during a therapeutic tumorectomy procedure involving a PowerSeal. There was no delay and the procedure was complete with an Olympus back up device. There was no patient harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913316 ↗
• MalfunctionSep 25, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902637 ↗
• MalfunctionSep 24, 2026Contamination /Decontamination Problem

  The customer reported that there were black stains at multiple locations on the main body, involving an Olympus Power Seal curved jaw sealer. There was no procedure involved. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883214 ↗
• MalfunctionSep 24, 2026Contamination /Decontamination Problem

  The customer reported that there were black stains at multiple locations on the main body, involving an Olympus Power Seal curved jaw sealer. There was no procedure involved. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883032 ↗
• MalfunctionSep 24, 2026Contamination /Decontamination Problem

  The customer reported that there were black stains at multiple locations on the main body, involving an Olympus Power Seal curved jaw sealer. There was no procedure involved. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882923 ↗
• MalfunctionSep 23, 2026Failure to Deliver Energy

  The customer reported that the output pathway though had stopped, involving an Olympus Power Seal curved jaw sealer. The procedure type was therapeutic, the procedure name was unknown. The intended procedure was completed with an Olympus back-up device. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871333 ↗
• MalfunctionSep 22, 2026Failure to Seal

  It was reported that during a therapeutic unknown procedure, the Powerseal curved jaw sealer and divider, would close and activate but would not seal. The customer stated attempts were made to change devices and cutting different tissue, but the issue did not resolve. A backup device was used to complete the procedure. No reports of patient injury or adverse patient effects.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859004 ↗
• MalfunctionSep 21, 2026Failure to Power Up

  The customer reported that the subject device did not power on the first attempt, and even after trying about three times, there was no change in function, involving an Olympus Zoom Microscope Body. The issue was found during a Left adrenalectomy Therapeutic procedure. The intended procedure was completed with an Olympus back-up device. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845930 ↗
• MalfunctionSep 16, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796444 ↗
• MalfunctionSep 16, 2026Failure to Seal

  The customer reported that the subject device had poor grounding, involving an Olympus PowerSeal curved Jaw sealer. The issue was found during an unknown Therapeutic procedure. There was no patient injury or harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793821 ↗
• MalfunctionSep 16, 2026Failure to Deliver Energy; Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782428 ↗
• MalfunctionSep 15, 2026Failure to Seal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779634 ↗

Other Gyrus ACMI, LLC products

• SOLTIVE16 models · 867 reports · 17 recalls
• SHOCKPULSE11 models · 580 reports · 5 recalls
• EZDilate7 models · 33 reports · 6 recalls
• Spiration Valve System10 models · 242 reports · 1 recall
• BiCOAG4 models · 36 reports · 5 recalls
• USA Elite24 models · 78 reports · 3 recalls
• M3 Gold5 models · 30 reports · 2 recalls
• PK TECHNOLOGY10 models · 24 reports · 2 recalls