The Recall Desk

Manufacturer

Olympus Corporation of the Americas

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

What the numbers show

Total
415
Critical
27
Severe
40
Most recent
2026-09-02

Of the 415 recalls from Olympus Corporation of the Americas we have scored against our rubric, 27 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 40 (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.

301–325 of 415

  • ModerateFDA (Devices)·Z-1616-2023·2023-05-31

    Olympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance

    Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.

    Product
    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1615-2023·2023-05-31

    ViziShot 2 Aspiration Needle recalled for manufacturing angle defect

    ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.

    Product
    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1418-2023·2023-04-26

    Olympus Single-Use Endoscopic Clip Fixing Device Recalled for Deployment Failure

    Olympus is recalling single-use rotatable clip fixing devices used in endoscopy procedures. The clips may fail to deploy from the tube sheath during use.

    Product
    Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2023·2023-02-22

    Olympus colonovideoscope recalled for potential microbial contamination from veterinary use

    An Olympus EVIS EXERA III colonovideoscope was used in veterinary endoscopy before being designated as a medical facility loaner, creating potential for microbial contamination.

    Product
    EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2023·2023-02-15

    Thoracic Navigation System Recalled for Incorrect Cable Causing Grainy Imaging

    Olympus is recalling the SPiN Thoracic Navigation System (model SYS-4000) due to an incorrect DVI cable that produces grainy images during bronchoscopy procedures, requiring extended troubleshooting time.

    Product
    SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0424-2023·2022-12-14

    HF Resection Electrodes Recalled for Incompatible Packaged Cable

    Olympus Corporation is recalling HF Resection Electrodes because an incompatible cable may be included in packaging. The cable cannot connect to the electrosurgical generator, potentially delaying or canceling surgery.

    Product
    HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2023·2022-10-19

    Olympus VC-10 Vacuum Curettage System Recalled for Incompatible Accessories

    Olympus recalls the VC-10 Vacuum Curettage System due to serious injury risk from incompatible collection canisters. The FDA warns users against using accessories not listed in the device's instructions.

    Product
    Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2022·2022-10-05

    Olympus POWERSEAL 5MM Electrosurgical Sealer Recalled Due to Loose Retention Ring

    Olympus is recalling POWERSEAL 5MM electrosurgical sealers due to a component defect that may cause the rotation knob to loosen and delay surgical treatment.

    Product
    Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2022·2022-10-05

    Olympus POWERSEAL Electrosurgical Device Recalled for Retention Ring Malfunction

    Olympus POWERSEAL electrosurgical devices are recalled for a component defect that may prevent the retention ring from securing the rotation knob, potentially delaying treatment.

    Product
    Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2022·2022-10-05

    Olympus POWERSEAL surgical sealer recalled for loose retention ring defect

    Olympus Corporation is recalling certain POWERSEAL electrosurgical sealers due to an out-of-specification component that may allow the retention ring to loosen, potentially delaying surgical treatment.

    Product
    Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2022·2022-08-17

    Lithotripsy Generator Recall Due to Mis-Wired Component Affecting System Reliability

    Olympus Corporation recalls 2 units of the ShockPulse-SE Lithotripsy Generator due to a mis-wired component that causes improper power supply noise and EMC non-compliance, potentially affecting device reliability and treatment delivery.

    Product
    ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2022·2022-07-06

    SOLTIVE SuperPulsed Laser Fibers recalled for model and size labeling mismatch

    Olympus is recalling certain SOLTIVE SuperPulsed Laser Fibers because device model and size may be mismatched between packaging and the actual device. This could result in the wrong laser fiber being used in medical procedures.

    Product
    SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1275-2022·2022-06-29

    EVIS EXERA II Gastrointestinal Videoscope Recalled for Incorrect Component Fit

    Olympus is recalling 8 EVIS EXERA II gastrointestinal videoscopes (Model GIF-HQ190) because an incorrect rubber component may have been installed during repair. The incorrect part does not meet the device's design specifications.

    Product
    EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2022·2022-06-29

    Colonovideoscope Model CF-H180AL recalled due to narrowed viewing angle

    Olympus Corporation recalls a single colonovideoscope model CF-H180AL because an incorrect camera unit was installed, causing narrower viewing angle and potential device protrusion that could injure tissue. No injuries have been reported.

    Product
    Colonovideoscope Model CF-H180AL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2022·2022-06-22

    Olympus Fiberscope Recalled for Defective Diopter Ring Adhesive

    Olympus URETERO-RENO FIBERSCOPE Model URF-P6R recalled due to incorrect adhesive securing the diopter ring, which may cause loss of focus and in rare cases urinary tract perforation.

    Product
    Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1263-2022·2022-06-22

    Olympus Uretero-Reno Fiberscope Recalled for Defective Adhesive and Vision Loss

    The Olympus URETERO-RENO FIBERSCOPE Model URF-P6 is recalled for incorrect adhesive securing the diopter ring. The defect may cause loss of adjustment function, blurred vision, and in rare cases, urinary tract perforation.

    Product
    Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1262-2022·2022-06-22

    Olympus endoscope diopter ring adhesive failure may impair vision

    Olympus endoscopes with defective diopter ring adhesive may cause vision loss and, in rare cases, urinary tract perforation.

    Product
    Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1116-2022·2022-05-25

    Olympus Uretero-reno Videoscope Bending Section May Crack and Deform

    The bending section of the Olympus URF-V2 videoscope may crack and develop abnormal shape or angulation. This could affect the device's function during urological procedures.

    Product
    Olympus Uretero-reno videoscope, Model No. URF-V2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1048-2022·2022-05-18

    Bronchofibervideoscope Sterilization and Disinfection Procedure Update Recall

    Olympus is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope due to updated instructions required for proper sterilization and reprocessing procedures. Updated guidance for chemical reprocessing, ETO gas sterilization, and disinfection rinsing steps is necessary.

    Product
    BF-MP160F: EVIS EXERA Bronchofibervideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2022·2022-05-18

    Bronchovideoscope Recall for Updated Sterilization and Reprocessing Instructions

    Olympus bronchovideoscopes are recalled due to updates required for proper sterilization and reprocessing procedures. Healthcare providers must follow new instructions for chemical disinfection and ETO gas sterilization.

    Product
    BF-1TQ180: EVIS EXERA II Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2022·2022-05-18

    Bronchovideoscope Reprocessing Instructions Updated Due to Sterilization Concerns

    Olympus is issuing updated instructions for reprocessing its EVIS EXERA bronchovideoscopes to ensure proper sterilization and disinfection procedures. Improper reprocessing could compromise device safety.

    Product
    BF-3C160: EVIS EXERA Bronchovideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2022·2022-05-11

    Ultrasonic Gastrovideoscope Recalled Due to Reprocessing Incompatibility and Infection Control Risk

    Olympus recalls the GF-UC140P-AL5 ultrasonic gastrovideoscope nationwide because it is no longer compatible with the OER-Pro reprocessing system, creating an infection control risk to patients.

    Product
    Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0638-2022·2022-02-23

    Endoscope Reprocessor Tubing Assembly Error May Reduce Disinfection Effectiveness

    Olympus OER-Elite Endoscope Reprocessors may have incorrectly assembled detergent and alcohol tank tubing, causing solutions to be dispensed in reversed cycles. This results in ineffective endoscope disinfection and potential patient exposure to residual detergent.

    Product
    OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide