The Recall Desk

Manufacturer

Olympus America Inc.

4 recalls in our database name Olympus America Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2015-09-30

Of the 4 recalls from Olympus America Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–4 of 4

  • ModerateFDA (Devices)·Z-2807-2015·2015-09-30

    Olympus TJF-Q180V Duodenoscope Recall Issued for Revised Reprocessing Procedures

    Olympus America Inc. is recalling 6,109 TJF-Q180V duodenoscopes to implement new cleaning and disinfection procedures.

    Product
    EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for end
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2014·2013-12-11

    Olympus Recalls Thunderbeat Surgical Instruments Due to Component Damage

    Olympus America Inc. is recalling Thunderbeat surgical instruments because they may crack, break, or deform during use.

    Product
    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2014·2013-11-27

    Olympus Endoscopic Flushing Pump Recalled for Potential Standby Mode Failure

    Olympus America Inc. is recalling 263 Endoscopic Flushing Pumps because the pump head may not be locked, potentially causing the device to stop and enter power stand-by mode during procedures.

    Product
    Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1277-2013·2013-05-15

    Olympus UES-40 Electrosurgical Unit Recalled for Overheating and Smoke

    Olympus America Inc. is recalling 608 UES-40 electrosurgical units due to overheating, smoke vapors, and operational failures.

    Product
    Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroen
    Category
    Medical Device
    Distribution
    Distributed nationwide