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.

51–75 of 423

  • HighFDA (Devices)·Z-1494-2026·2026-03-11

    Olympus lithotripsy systems recalled over mis-wired component causing electrical noise

    Olympus is expanding a recall of ShockPulse-SE Lithotripsy Systems after finding additional generators with a mis-wired component that adds noise to the power supply output.

    Product
    Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1453-2026·2026-03-04

    Olympus Inner Sheath 21 Fr. Model A2660T Medical Device Recall

    Olympus is recalling all lots of its Inner Sheath 21 Fr. Model A2660T used in urological procedures due to reports of the ceramic tip breaking during use.

    Product
    Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1455-2026·2026-03-04

    Olympus Inner Sheath Model A2641 Recalled Over Ceramic Tip Breakage

    Olympus is recalling all lots of its Inner Sheath, Model A2641, used in urological endoscopic procedures, due to complaints that the ceramic tip can break during use.

    Product
    Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1446-2026·2026-03-04

    Olympus resection sheath recalled due to ceramic tip breakage

    Olympus is recalling 207 units of its Resection Sheath, Model A22043T, after receiving complaints that the ceramic tip can break during use. The recall affects all lots distributed nationwide.

    Product
    Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2026·2026-03-04

    Olympus resection sheath recalled due to ceramic tip breakage

    Olympus is recalling 3,484 Resection Sheaths, Model A22041A, after receiving complaints that the ceramic tip can break during urologic procedures. The recall covers all lots distributed nationwide.

    Product
    Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2026·2026-03-04

    Olympus Gynecological Resection Sheath Recalled Over Ceramic Tip Breakage

    Olympus is recalling 899 units of its 8 mm Resection Sheath (Model A42011A) used in gynecological procedures after receiving complaints that the ceramic tip can break during use.

    Product
    Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2026·2026-03-04

    Olympus Resection Sheath Recalled Due to Ceramic Tip Breaking

    Olympus is recalling 1,676 resection sheaths after complaints of ceramic tips breaking during urologic procedures.

    Product
    Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2026·2026-03-04

    Olympus Inner Sheath Medical Device Recalled Due to Ceramic Tip Breakage

    Olympus is recalling its Inner Sheath Model A2642, a medical device used in urological procedures, after receiving complaints that the ceramic tip can break during use.

    Product
    Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2026·2026-03-04

    Olympus Resection Sheath Model A2666 Recalled Due to Ceramic Tip Breakage

    Olympus recalls Model A2666 Resection Sheath for urologic use after receiving complaints of the ceramic tip breaking during procedures.

    Product
    Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2026·2026-03-04

    Olympus 26 French resection sheath recalled over ceramic tip breakage

    Olympus is recalling its Resection Sheath, 26 Fr, with Deflecting Obturator, model A22042T, used in urologic applications, after complaints that the ceramic tip can break.

    Product
    Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2026·2026-03-04

    Olympus resection sheath models A22014A and A22014T recalled for breakage

    Olympus is recalling Resection Sheath models A22014A and A22014T, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.

    Product
    Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2026·2026-03-04

    Olympus resection sheath recalled after reports of ceramic tip breaking

    Olympus is recalling its Resection Sheath model A2666T, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip of the sheath can break.

    Product
    Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2026·2026-03-04

    Olympus 28 French resection sheath recalled over ceramic tip breakage

    Olympus is recalling its Resection Sheath, 28 Fr, model A22043A, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2026·2026-03-04

    Olympus Cystoscope Outer Sheath Recalled Due to Potential Device Tip Damage

    Olympus Corporation of the Americas is recalling Olympus Cystoscope Outer Sheath (Model WA22810A) because it may be incompatible with GreenLight Laser therapy, potentially damaging the device tip.

    Product
    Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2026·2026-03-04

    Olympus 10 French sheath recalled over ceramic tip breakage complaints

    Olympus is recalling its Sheath, 10 Fr, model A37004A, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.

    Product
    Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2026·2026-03-04

    Olympus 24 French resection sheath recalled over ceramic tip breakage

    Olympus is recalling its Resection Sheath, 24 Fr, with Deflecting Obturator, model A22041T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2026·2026-03-04

    Olympus inner sheath model A2660 recalled over ceramic tip breakage

    Olympus is recalling its Inner Sheath, model A2660, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2026·2026-03-04

    Olympus resection inner sheath A22040A recalled over ceramic tip breakage

    Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040A, used in urologic applications, after complaints that the ceramic tip can break.

    Product
    Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1440-2026·2026-03-04

    Olympus resection inner sheath recalled after ceramic tip breakage complaints

    Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2026·2026-03-04

    Olympus long inner sheath recalled after ceramic tip breakage complaints

    Olympus is recalling its Inner Sheath, Long, model WA22017A, used in urological and gynecological applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2026·2026-03-04

    Olympus Inner Sheath Medical Device Recall for Ceramic Tip Breakage

    Olympus recalls 91 units of its Inner Sheath Model A4741 medical device after receiving complaints of the ceramic tip breaking during gynecological endoscopic procedures.

    Product
    Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1353-2026·2026-02-25

    Olympus High Flow Insufflation Unit Model UHI-2 Recalled Due to Software Issue

    Olympus Corporation of the Americas is recalling 744 Olympus High Flow Insufflation Units (Model UHI-2) because a software algorithm issue may cause overpressure events.

    Product
    Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1354-2026·2026-02-25

    Olympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk

    Olympus is recalling 485 High Flow Insufflation Units (Model UHI-3) nationwide due to a software algorithm issue that may cause dangerous overpressure during abdominal surgery.

    Product
    Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1371-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recall Due to Adverse Events

    Olympus is recalling 9,542 Thunderbeat surgical devices worldwide due to continued reports of adverse events. The recall affects all lots of the TB-0545FCS model.

    Product
    Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide