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Olympus America, Inc.

Country not established

Devices
149
FDA recalls
21

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Olympus America, Inc. makes

Olympus America, Inc. manufactures endoscopic systems for general surgery, including 3D surgical endoscopy platforms and mini laparoscopy tools. Their portfolio also includes biopsy forceps—both cold and hot variants—and grasping instruments like basket graspers for procedural applications. Diagnostic reagents for clinical chemistry are produced, such as unsaturated iron binding capacity, CK-MB, and rheumatoid factor assays, alongside an automated clinical chemistry analyzer (AU5400). Bronchial ultrasonic probes and associated ancillary equipment are also part of their device offerings.

The company’s devices are regulated under FDA 510(k) clearance, spanning Class I and Class II classifications. Products are listed in the FDA’s 510(k) database, reflecting their authorised status for market distribution in the United States. Olympus America, Inc. is headquartered in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue149

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FDA recalls21

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 21 recalls initiated by Olympus America, Inc., the earliest on 2003-03-05 and the most recent on 2015-03-26. By recorded status: 21 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, packaging, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 21 recalls.

  • 2015

    • 26 Mar 2015 Z-2807-2015 Class II Terminated New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures. Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico. Submission number: K080403

  • 2013

    • 27 Sep 2013 Z-0432-2014 Class II Terminated Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw. Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada. Submission number: K111202
    • 20 May 2013 Z-0329-2014 Class II Terminated There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode. Distribution: Worldwide distribution: USA (nationwide) and the country of Canada. Submission number: K100899

  • 2011

    • 27 Dec 2011 Z-0828-2012 Unclassified (pre-2012) Terminated Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements Distribution: Nationwide Distribution-including Washington, D.C. and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS,…
      Full distribution text Nationwide Distribution-including Washington, D.C. and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, and WI.
      Submission number: K030194
    • 27 Dec 2011 Z-0829-2012 Unclassified (pre-2012) Terminated Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements Distribution: Nationwide Distribution-including Washington, D.C. and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS,…
      Full distribution text Nationwide Distribution-including Washington, D.C. and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, and WI.
      Submission number: K030194
    • 12 Dec 2011 Z-0806-2012 Unclassified (pre-2012) Terminated Water may leak from the irrigation tubing used on the Olympus Flushing Pump Distribution: Nationwide distribution: USA including states of: AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS,…
      Full distribution text Nationwide distribution: USA including states of: AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, AND WY.
      Submission number: K000948
    • 28 Nov 2011 Z-0747-2012 Unclassified (pre-2012) Terminated Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100. Distribution: Nationwide Distribution. Submission number: K073207
    • 28 Oct 2011 Z-1160-2012 Unclassified (pre-2012) Terminated Replacement wheels may break off from the base of the cart Distribution: Nationwide Distribution including AL, CA, NY and WV.
    • 25 Aug 2011 Z-0029-2012 Unclassified (pre-2012) Terminated Firm has received complaints from users of the ability to wipe material from the needle's stylet and the presence of material in patient cytology samples obtained by the needle following endobronchial ultrasound fine needle aspiration of a lesion. Olympus Medical Systems Corporation (OMSC) in Japan has confirmed that metal particles can occur on the stylet due to friction between the stylet and n Distribution: Nationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL,…
      Full distribution text Nationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.
      Submission number: K050503

  • 2010

    • 22 Dec 2010 Z-3102-2011 Unclassified (pre-2012) Terminated The device sterile package seal shows evidence of being breached or was breached Distribution: USA (nationwide) including the states of AL, AR, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND,…
      Full distribution text USA (nationwide) including the states of AL, AR, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OR, TX, VA, VT, and WI.
      Submission number: K904939
Show all 21 recalls

  • 2010

    • 20 Aug 2010 Z-2642-2010 Unclassified (pre-2012) Terminated Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type. Distribution: nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe
    • 3 May 2010 Z-2236-2010 Unclassified (pre-2012) Terminated An investigation of consumer complaints revealed the inability of the snare wire to be retracted into the snare tube after deployment of the snare. Distribution: Nationwide Distribution -- AR, CA, CO, CT, DC, FL, GA, IN, KS, LA, MD, MO, NC, NY, OH, PA, SC, TN, and TX. Submission number: K955650
    • 8 Feb 2010 Z-1163-2010 Unclassified (pre-2012) Terminated weak weld seams Distribution: Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada Submission numbers: K790071, K923982

  • 2009

    • 10 Nov 2009 Z-1277-2013 Class II Terminated Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that Distribution: Nationwide Distribution - USA Nationwide including the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS,…
      Full distribution text Nationwide Distribution - USA Nationwide including the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WY.
      Submission number: K030194

  • 2007

    • 20 Sep 2007 Z-0105-2008 Unclassified (pre-2012) Terminated Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath Distribution: Nationwide Submission number: K903529
    • 20 Sep 2007 Z-0106-2008 Unclassified (pre-2012) Terminated Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath Distribution: Nationwide Submission number: K903529
    • 20 Sep 2007 Z-0107-2008 Unclassified (pre-2012) Terminated Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath Distribution: Nationwide Submission number: K903529
    • 20 Sep 2007 Z-0108-2008 Unclassified (pre-2012) Terminated Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath Distribution: Nationwide Submission number: K903529

  • 2005

    • 18 Nov 2005 Z-0322-06 Unclassified (pre-2012) Terminated Lab Automation System may dilute samples with water. Distribution: Nationwide; Distribution was made to laboratories and blood centers located in CA, CO, GA, NC, and OH.

  • 2003

    • 19 Aug 2003 Z-0047-04 Unclassified (pre-2012) Terminated Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file. Distribution: Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador…
      Full distribution text Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.
      Submission numbers: K934888, K934889
    • 5 Mar 2003 Z-1126-03 Unclassified (pre-2012) Terminated Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system. Distribution: Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico. Submission numbers: K934888, K934889

Frequently asked questions

How many devices does Olympus America, Inc. have in the registry?

The registry currently lists 149 devices for Olympus America, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Olympus America, Inc.'s devices?

Among its 50 most recently registered devices, Olympus America, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Olympus America, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Olympus America, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Olympus America, Inc.?

FDA recall records list 21 recalls initiated by Olympus America, Inc., the most recent initiated on 2015-03-26. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Olympus America, Inc. in the registry?

The most recently registered devices listed for Olympus America, Inc. include 3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY, OLYMPUS FG-45/46-1 GRASPING FORCEPS, OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT and OLYMPUS FB SERIES BIOPSY FORCEPS.

Generated automatically from registry data and not verified by a human reviewer.