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.

1–25 of 332

  • HighFDA (Devices)·Z-1854-2026·2026-04-29

    Olympus Thunderbeat II Shears Ultrasonic Mode distal tip detachment risk

    Olympus is recalling Thunderbeat II Shears (5mm, 45cm) because the distal tip component may detach during use, potentially causing patient harm.

    Product
    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1906-2026·2026-04-29

    Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled

    Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2118) due to potential premature failure of Version 2 reprocessor connecting tube lock levers. The recall affects 1,259 units distributed worldwide.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2026·2026-04-29

    Olympus Thunderbeat II Surgical Shears Recalled for Distal Tip Detachment Risk

    Olympus is recalling Thunderbeat II ultrasonic surgical shears (Model TB2-0525FC) due to potential detachment of the distal tip component during use.

    Product
    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1851-2026·2026-04-29

    Olympus Thunderbeat II Shears recall due to distal tip detachment

    Olympus Corporation of the Americas is recalling Olympus Thunderbeat II Shears (Model TB2-0520FC) because the distal tip component may detach during use.

    Product
    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1853-2026·2026-04-29

    Olympus Thunderbeat II surgical shears recalled for potential distal tip detachment

    Olympus is recalling Thunderbeat II 5mm ultrasonic surgical shears (model TB2-0535FC) due to potential detachment of the distal tip component during use. Approximately 3,360 units have been distributed internationally.

    Product
    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1904-2026·2026-04-29

    Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2116) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1907-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Failure Recall

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2119) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1898-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2110) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The tubes are used to reprocess endoscopes.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1905-2026·2026-04-29

    Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2117) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Levers Failure Risk

    Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2330) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1899-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1908-2026·2026-04-29

    Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2138) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers. The defect could affect proper tube attachment during endoscope reprocessing.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1900-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2112) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1901-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2113) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The defect could affect proper connection during endoscope reprocessing.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1903-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled Nationwide

    Olympus Corporation recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure Risk

    Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety during endoscope reprocessing.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1695-2026·2026-04-08

    Olympus SOLTIVE Pro Laser System power supply defect recall

    Olympus is recalling SOLTIVE Pro Laser Systems with defective 24V power supply modules that may cause device malfunction, smoke, or burning smell. 32 units distributed worldwide.

    Product
    Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1694-2026·2026-04-08

    Olympus SOLTIVE laser system power supply defect recall

    Olympus is recalling SOLTIVE laser systems due to a potential 24V power supply defect that could cause system malfunction, smoke, or burning smell. The fire risk is contained by design and self-extinguishing.

    Product
    Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2026·2026-04-01

    Olympus PK Cutting Forceps recalled due to defective welds

    Olympus is recalling 444 units of the PK Cutting Forceps (Model PK-CF0533) worldwide because defective welds in supplier-provided components can cause the instrument's jaw to break during surgical use.

    Product
    Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1612-2026·2026-04-01

    Olympus Endoscope Reprocessor OER-Elite Loses Compatibility with MAJ-1443 and MAJ-1444 Models

    Olympus Endoscope Reprocessor OER-Elite is no longer compatible with MAJ-1443 and MAJ-1444 endoscope models. Affected endoscopes may not be properly sterilized when processed in this reprocessor, creating infection risk.

    Product
    Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2026·2026-04-01

    Olympus OER-Pro endoscope reprocessor incompatible with MAJ accessories

    Olympus Corporation of the Americas is recalling 3,354 units of the OER-Pro endoscope reprocessor because MAJ-1443 and MAJ-1444 accessories are no longer compatible with it.

    Product
    Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2026·2026-04-01

    Olympus Bipolar Cutting Forceps Recalled Over Defective Welds

    Olympus recalled 106 Everest Bipolar Cutting Forceps (Model 3005) due to defective welds in supplier-provided components. The defect can cause the forceps' jaw to break during surgery.

    Product
    Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2026·2026-04-01

    Olympus PKS Surgical Cutting Forceps recalled for defective welds

    Olympus Corporation recalled PKS Cutting Forceps due to inadequate welding validation by suppliers, which can cause the device's jaw to break during surgical use.

    Product
    Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1610-2026·2026-04-01

    Olympus Endoscope Suction Valve recalled for reprocessor incompatibility

    Olympus Corporation is recalling the MAJ-1443 endoscope suction valve because it is no longer compatible with OER-Pro and OER-Elite automated endoscope reprocessors. Improper reprocessing could compromise sterilization of medical equipment.

    Product
    Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2026·2026-04-01

    Olympus PKS Cutting Forceps recalled due to defective weld fracture risk

    Olympus is recalling PKS Cutting Forceps worldwide due to defective welds in supplier components. The surgical instrument's jaw can break during clinical use.

    Product
    Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualiza
    Category
    Medical Device
    Distribution
    Distributed nationwide