Olympus Corporation of the Americas recall records

323 reported ongoing

327 records in this archive. Latest source date Aug 18, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: RE...

Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

Class IIReported ongoing

Distribution: US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.

Official source for ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series ...
FDA device enforcement

TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA, IL, IN, MA, MD, MI, NC, NJ, OH, TX, UT, VA, WA, WV & AP (Armed Forces Pacific) and the countries of O...

Official source for TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
FDA device enforcement

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 d...

Class IReported ongoing

Distribution: US Nationwide distribution.

Official source for Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
FDA device enforcement

EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other an...

Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera h...
FDA device enforcement

THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery ...

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparos...
FDA device enforcement

THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (...

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparosc...
FDA device enforcement

Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPi...

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Official source for Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50H...
FDA device enforcement

Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN A...

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Official source for Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes I...
FDA device enforcement

Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿...

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Official source for Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes IN...
FDA device enforcement

Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1...

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Official source for Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx...
FDA device enforcement

Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW ...

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Official source for Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12...
FDA device enforcement

Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1...

Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Official source for Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX I...

Reasons in these listed records

  • There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
  • Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
  • Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
  • Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

These examples come from this result page and are not a ranking of every recall reason.

Checking Olympus Corporation of the Americas

Is there a recall on olympus corporation of the americas right now?

This archive contains 327 records, including 323 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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