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.

26–50 of 332

  • 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
  • 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-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
  • ModerateFDA (Devices)·Z-1611-2026·2026-04-01

    Olympus Endoscope Air/Water Valve Models Lose Reprocessor Compatibility

    Olympus Endoscope Air/Water Valves MAJ-1443 and MAJ-1444 are no longer compatible with OER-Pro and OER-Elite automated reprocessors. Users should discontinue using these valves with these reprocessing systems.

    Product
    Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2026·2026-03-11

    ShockPulse-SE Lithotripsy System may fail to recognize transducer probe

    Olympus recalled ShockPulse-SE Lithotripsy Systems where the generator fails to recognize the transducer probe. The issue affects 1,082 units distributed worldwide.

    Product
    Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1488-2026·2026-03-11

    Olympus Biopsy Valve Recalled Due to Potential Rubber Fragment Detachment

    Olympus Corporation is recalling approximately 95,882 boxes of MAJ-210 Single use Biopsy Valves nationwide due to potential for rubber fragments to detach during endoscopic procedures.

    Product
    Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1489-2026·2026-03-11

    Olympus Single Use Biopsy Valve Recalled Due to Rubber Fragment Detachment Risk

    Olympus is recalling its Single Use Biopsy Valve (Model MAJ-1218) due to potential rubber fragments detaching during use. The product has been distributed nationwide.

    Product
    Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2026·2026-03-11

    Olympus ShockPulse-SE Lithotripsy System Generator Connector Malfunction Recall

    Olympus is recalling 602 ShockPulse-SE Lithotripsy Systems due to generator malfunction caused by connector damage. The generator may fail to recognize the transducer, preventing proper device operation during stone fragmentation procedures.

    Product
    Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1479-2026·2026-03-11

    Olympus ShockPulse-SE Lithotripsy Generator Recalled for Transducer Recognition Failure

    Olympus is recalling the ShockPulse-SE Lithotripsy System generator because damage to the transducer plug or generator receptacle may cause the device to remain in a blinking state and fail to recognize the transducer. The 1,684 affected units were distributed worldwide.

    Product
    Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1494-2026·2026-03-11

    Olympus ShockPulse-SE Lithotripsy System Generator Mis-wired Component Recall

    Olympus ShockPulse-SE lithotripsy system generators have a mis-wired component causing electrical noise that violates electromagnetic compatibility standards. This may reduce system reliability and delay kidney stone treatment. 55 units affected in Canada, Germany, Singapore, Australia, and India.

    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
  • HighFDA (Devices)·Z-1438-2026·2026-03-04

    Olympus Resection Sheath recalled for ceramic tip fracture

    Olympus is recalling Resection Sheath models A22014A and A22014T, used in urological endoscopy, after receiving complaints of ceramic tip breaking.

    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-1452-2026·2026-03-04

    Olympus Resection Sheath ceramic tip may break during use

    Olympus is recalling Resection Sheath Model A2666 due to reports that the ceramic tip can break during urologic surgical procedures. The company has received complaints about this device failure.

    Product
    Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2026·2026-03-04

    Olympus Resection Sheath Ceramic Tip Breaking Defect Recall

    Olympus Corporation is recalling the Resection Sheath, 24 Fr (Model A22041A) nationwide due to complaints that the ceramic tip can break during urologic procedures.

    Product
    Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2026·2026-03-04

    Olympus Inner Sheath Model A2660 Recall Due to Ceramic Tip Fracture

    Olympus Corporation recalls the Inner Sheath Model A2660 used in urological endoscopic procedures due to complaints that the ceramic tip can break during use. No injuries have been reported.

    Product
    Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2026·2026-03-04

    Olympus Inner Sheath Recalled for Ceramic Tip Breakage in Medical Procedures

    Olympus is recalling the Inner Sheath, Long (Model WA22017A) used in urological and gynecological procedures due to complaints of ceramic tip breakage. Medical facilities should stop using the device and contact Olympus.

    Product
    Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2026·2026-03-04

    Olympus Inner Sheath Model A2642 Recalled for Breaking Ceramic Tip

    Olympus is recalling the Inner Sheath Model A2642 urological endoscope due to complaints that the ceramic tip breaks. The device has been distributed nationwide.

    Product
    Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2026·2026-03-04

    Olympus Resection Sheath Recalled Due to Ceramic Tip Fracture Risk

    Olympus Corporation recalls 94 units of Model A37004A resection sheath used in urological procedures. Complaints indicate the ceramic tip can break during use.

    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-1457-2026·2026-03-04

    Olympus Resection Sheath ceramic tip breakage medical device recall

    Olympus Corporation is recalling the Olympus Resection Sheath Model A2666T due to complaints of the ceramic tip breaking. The device is used for urological procedures and distributed nationwide.

    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 Resection Sheath Recalled for Ceramic Tip Breakage

    Olympus is recalling 118 Resection Sheaths (Model A22043A) distributed nationwide due to complaints of ceramic tip breakage during urologic procedures.

    Product
    Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2026·2026-03-04

    Olympus Model A4741 Inner Sheath Recalled Due to Ceramic Tip Breakage

    Olympus Corporation recalls 91 units of Model A4741 Inner Sheath following complaints that the ceramic tip breaks. The device is used for endoscopic gynecological diagnosis and treatment.

    Product
    Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2026·2026-03-04

    Olympus Resection Sheath 8 mm Model A42011A Recalled for Ceramic Tip Breakage

    Olympus is recalling Resection Sheath Model A42011A due to complaints that the ceramic tip can break. The recall affects 899 units distributed nationwide in the United States.

    Product
    Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2026·2026-03-04

    Olympus Resection Inner Sheath Recalled for Ceramic Tip Breakage

    Olympus Corporation is recalling the Olympus Resection Inner Sheath (Model A22040A) due to reports of the ceramic tip breaking. The recall affects 6,949 units distributed nationwide.

    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-1437-2026·2026-03-04

    Olympus Cystoscope Outer Sheath Recalled for GreenLight Laser Incompatibility

    Olympus is recalling 633 Cystoscope Outer Sheath units (Model WA22810A) nationwide due to incompatibility with GreenLight Laser equipment for BPH therapy. The incompatibility could damage the device tip during use.

    Product
    Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2026·2026-03-04

    Olympus Resection Sheath Recalled Due to Ceramic Tip Fracture Risk

    Olympus Corporation of the Americas is recalling the Olympus Resection Sheath (Model A22042T) due to reports that the ceramic tip can break. The defect affects 1,634 units distributed nationwide.

    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-1453-2026·2026-03-04

    Olympus Inner Sheath Urological Endoscope Model A2660T Recall

    Olympus is recalling Inner Sheath 21 Fr. endoscopes due to complaints of ceramic tip breakage during use. The broken tip could cause tissue damage in urological procedures.

    Product
    Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide