The Recall Desk

Manufacturer

Olympus Corporation of the Americas

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

What the numbers show

Total
423
Critical
27
Severe
41
Most recent
2026-10-07

Of the 423 recalls from Olympus Corporation of the Americas we have scored against our rubric, 27 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 41 (10%) are Severe.

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 423

  • ModerateFDA (Devices)·Z-3299-2026·2026-10-07

    Olympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy

    Olympus Corporation of the Americas is recalling 72 units of the M3 Gold Autoclavable Foroblique Telescope 30 due to discrepancies between sterilization parameters in the Instructions for Use and the Japanese package insert.

    Product
    Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3329-2026·2026-10-07

    Olympus DisplayPort Cable Recalled for Video Dropout Risk

    Olympus is recalling 543 DisplayPort cables used with the OLYSENSE Hub System because they may cause video dropouts or blackouts during high-power operation.

    Product
    Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3244-2026·2026-09-30

    Olympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk

    Olympus is recalling 404 BiCOAG Hemostasis Probes because the ceramic tip may detach due to insufficient adhesive.

    Product
    Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3245-2026·2026-09-30

    Olympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk

    Olympus is recalling 105 BiCOAG Hemostasis Probes because a manufacturing defect may cause the ceramic tip to detach during use.

    Product
    Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3247-2026·2026-09-30

    Olympus BiCOAG Hemostasis Probe Recalled for Potential Ceramic Tip Detachment

    Olympus Corporation of the Americas is recalling 816 units of BiCOAG Hemostasis Probes because the ceramic tip may detach due to insufficient adhesive.

    Product
    Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3246-2026·2026-09-30

    Olympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk

    Olympus is recalling 2,142 BiCOAG Hemostasis Probes because a manufacturing error may cause the ceramic tip to detach.

    Product
    Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3216-2026·2026-09-30

    Olympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label

    Olympus is recalling 305 units of EZDilate Endoscopic Balloon Dilators because the inflation chart label may incorrectly indicate balloon diameters of 18, 19, or 20 mm.

    Product
    Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3035-2026·2026-09-02

    Olympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling

    Olympus is recalling 335 PowerSeal 5 mm Sealer & Divider devices because the outer shelf box is incorrectly labeled as a 37-cm device.

    Product
    POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2026·2026-07-29

    Olympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure

    Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI-4) because the front panel display may turn off unexpectedly, causing air delivery to cease.

    Product
    Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2761-2026·2026-07-29

    Olympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults

    Olympus Corporation of the Americas is recalling 10 Olympus 4K UHD LCD Monitors (Model OEV321UH) because the HDMI and DisplayPort connectors may become faulty.

    Product
    Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2720-2026·2026-07-22

    Olympus Ellik Evacuator Recalled for Inadequate Sterilization Risk

    Olympus Corporation of the Americas is recalling the Olympus Ellik Evacuator (Model 194) worldwide because certain sterilization parameters in the instructions may not render the device adequately sterile.

    Product
    Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2719-2026·2026-07-22

    Olympus Toomey Evacuator 50cc with Adaptor sterilization recall

    Olympus is recalling the Toomey Evacuator 50cc with Adaptor (Model 188A) because some sterilization parameters in the instructions may not reliably render the devices sterile.

    Product
    Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2721-2026·2026-07-22

    Olympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall

    Olympus Corporation is recalling the Glass Body for 194 Ellik Evacuator (Model 190A) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.

    Product
    Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2026·2026-07-22

    Olympus Toomey Evacuator 30cc medical device sterilization parameters recalled

    Olympus Corporation recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.

    Product
    Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2676-2026·2026-07-15

    Olympus Single Use Distal Cover MAJ-2315 Duodenovideoscope Replacement

    Olympus Corporation of the Americas is replacing the previous design of its Single Use Distal Cover (MAJ-2315) with a newly designed version for use with EVIS EXERA III Duodenovideoscopes.

    Product
    Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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
  • HighFDA (Devices)·Z-1853-2026·2026-04-29

    Olympus Thunderbeat II shears 35 cm may shed a distal tip component

    Olympus is recalling Thunderbeat II Shears with Ultrasonic Mode, 5 mm and 35 cm, because a distal tip component may detach during use. 3,360 units are affected.

    Product
    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1852-2026·2026-04-29

    Olympus Thunderbeat II shears 25 cm may shed a distal tip component

    Olympus is recalling Thunderbeat II Shears with Ultrasonic Mode, 5 mm and 25 cm, because a distal tip component may detach during use. 365 units are affected.

    Product
    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
    Category
    Medical Device
    Distribution
    0 states
  • 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-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
  • 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-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