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Olympus Corporation of the Americas
Olympus Corporation of the Americas: 414 FDA recall reports
Every medical device recall the FDA has published for Olympus Corporation of the Americas. The fault, and how the agency graded it.
414Reports
44Class I
323Ongoing
2026-07-29Most recent
44 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Z-2776-2026 · Class II · reported 2026-07-29 · Ongoing
- Why it was recalled
- Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
- Product
- Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong Kong, India, Ireland, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka, Taiwan, Thailand, United Kingdom, Uruguay, Vietnam.
- How much
- 3,087 units
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed fo
Z-2761-2026 · Class II · reported 2026-07-29 · Ongoing
- Why it was recalled
- Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
- Product
- Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
- Where it went
- Worldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the country of Japan.
- How much
- 10 units
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Z-2720-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
- Product
- Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
- How much
- 3,241 units
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Z-2718-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
- Product
- Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
- How much
- 190 units
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Z-2721-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
- Product
- Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
- How much
- 3,663 units
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Z-2719-2026 · Class II · reported 2026-07-22 · Ongoing
- Why it was recalled
- Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
- Product
- Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
- How much
- 1,156 units
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190
Z-2676-2026 · Class II · reported 2026-07-15 · Ongoing
- Why it was recalled
- Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
- Product
- Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
- Where it went
- US Nationwide distribution.
- How much
- 988700 units
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Z-1854-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for detachment of a distal tip component of the device during use.
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
- Where it went
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- How much
- 490 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Z-1903-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- XXX
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 2,089 units
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Z-1851-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for detachment of a distal tip component of the device during use.
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
- Where it went
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- How much
- 830 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Z-1901-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 8,936 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Z-1907-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 741 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Z-1902-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 2,143 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Z-1908-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 808 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Z-1906-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 1,259 units
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Z-1853-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for detachment of a distal tip component of the device during use.
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
- Where it went
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- How much
- 3,360 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Z-1900-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 8,994 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Z-1905-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 1,929 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the
Z-1898-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 9,757 units
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Z-1852-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for detachment of a distal tip component of the device during use.
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
- Where it went
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- How much
- 365 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Z-1899-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 10,141 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Z-1904-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 373 units
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Z-1909-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- How much
- 1,829 units
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-P
Z-1694-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
- Product
- Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
- How much
- 408 units
Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Mode
Z-1695-2026 · Class II · reported 2026-04-08 · Ongoing
- Why it was recalled
- Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
- Product
- Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
- How much
- 32 units
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 30
Z-1642-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking 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 visualization. The device is intended to be used with the PKS electrical generator.
- Where it went
- Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
- How much
- 93 units
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Z-1610-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Product
- Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
- Where it went
- US Nationwide distribution.
- How much
- 47,383 units
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Num
Z-1643-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical 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 visualization. The device is intended to be used with the PKS electrical generator.
- Where it went
- Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
- How much
- 7 units
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Z-1613-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Product
- Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
- Where it went
- US Nationwide distribution.
- How much
- 3,354 units
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-C
Z-1640-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical 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 during an endoscopic or open surgical procedure.
- Where it went
- Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
- How much
- 444 units
Showing the 30 most recent of 414. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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