PlainRecordsFDA · Medical device recall
Olympus High Flow Insufflation Unit… and 2 more products
- Reason
- Issue with software algorithm which may lead to overpressure events.
- Status
- Ongoing
- Distribution
- Nationwide distribution
- Enforcement report date
- Feb. 25, 2026
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Olympus Corporation of the Americas
- Reason
- Issue with software algorithm which may lead to overpressure events.
- Distribution pattern
- Nationwide distribution
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Issue with software algorithm which may lead to overpressure events.”Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity., FDA enforcement report, 2026-02-25. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Insufflator, Laparoscopic
3 products in this recall
Olympus High Flow Insufflation Unit…
- Product
- Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
- Quantity
- 18 units
- Codes and lots
- Model Number: UHI; UDI-DI: N/A; All Serial Numbers
- Recall started
- Jan. 16, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Insufflator, Laparoscopic
- Root cause (FDA)
- Software design
- What the company told customers
- Olympus notified consignees on about 01/16/2026 via "URGENT: MEDICAL DEVICE REMOVAL" letter. Consignees were instructed to cease usage of the affected product immediately. They are advised to use available alternatives including an existing UHI-4 if available or switching to an insufflation device from another manufacturer. If no alternative is available on site, contact Olympus to arrange a loaner or purchase a replacement. Additionally, consignees were instructed to examine inventory and quarantine any identified devices, immediately cease usage of any UHI, UHI-2, and/or UHI-3 in inventory, call Olympus Customer Service at 1-800-848-9024, option 2 to obtain a Return Material Authorization to return your device. Consignees were also requested to acknowledge receipt of this letter through their recall web portal as follows: a. Go to https://olympusamerica.com/recall, b. Enter the recall number "0489 and c. Complete the form as instructed. Please indicate in your response if you no longer have the device(s). If any consignees have further distributed this UHI product, they were instructed to identify affected customers and forward this notice to them immediately. If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 or by email at Cynthia.Ow@Olympus.com.
- Recall number
- Z-1352-2026
Olympus High Flow Insufflation Unit…
- Product
- Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
- Quantity
- 744 units
- Codes and lots
- Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers
- Recall started
- Jan. 16, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Insufflator, Laparoscopic
- Root cause (FDA)
- Software design
- What the company told customers
- Olympus notified consignees on about 01/16/2026 via "URGENT: MEDICAL DEVICE REMOVAL" letter. Consignees were instructed to cease usage of the affected product immediately. They are advised to use available alternatives including an existing UHI-4 if available or switching to an insufflation device from another manufacturer. If no alternative is available on site, contact Olympus to arrange a loaner or purchase a replacement. Additionally, consignees were instructed to examine inventory and quarantine any identified devices, immediately cease usage of any UHI, UHI-2, and/or UHI-3 in inventory, call Olympus Customer Service at 1-800-848-9024, option 2 to obtain a Return Material Authorization to return your device. Consignees were also requested to acknowledge receipt of this letter through their recall web portal as follows: a. Go to https://olympusamerica.com/recall, b. Enter the recall number "0489 and c. Complete the form as instructed. Please indicate in your response if you no longer have the device(s). If any consignees have further distributed this UHI product, they were instructed to identify affected customers and forward this notice to them immediately. If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 or by email at Cynthia.Ow@Olympus.com.
- Recall number
- Z-1353-2026
Olympus High Flow Insufflation Unit…
- Product
- Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
- Quantity
- 485 units
- Codes and lots
- Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.
- Recall started
- Jan. 16, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Insufflator, Laparoscopic
- Root cause (FDA)
- Software design
- What the company told customers
- Olympus notified consignees on about 01/16/2026 via "URGENT: MEDICAL DEVICE REMOVAL" letter. Consignees were instructed to cease usage of the affected product immediately. They are advised to use available alternatives including an existing UHI-4 if available or switching to an insufflation device from another manufacturer. If no alternative is available on site, contact Olympus to arrange a loaner or purchase a replacement. Additionally, consignees were instructed to examine inventory and quarantine any identified devices, immediately cease usage of any UHI, UHI-2, and/or UHI-3 in inventory, call Olympus Customer Service at 1-800-848-9024, option 2 to obtain a Return Material Authorization to return your device. Consignees were also requested to acknowledge receipt of this letter through their recall web portal as follows: a. Go to https://olympusamerica.com/recall, b. Enter the recall number "0489 and c. Complete the form as instructed. Please indicate in your response if you no longer have the device(s). If any consignees have further distributed this UHI product, they were instructed to identify affected customers and forward this notice to them immediately. If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 or by email at Cynthia.Ow@Olympus.com.
- Recall number
- Z-1354-2026
This recall among the others
- FDA's enforcement report came 40 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
- Olympus Corporation of the Americas: 73 other recalls or notices on this site in the three years before this one (from Feb. 26, 2023).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-1352-2026, Z-1353-2026, Z-1354-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1352-2026, Feb. 25, 2026. "Olympus High Flow Insufflation Unit… and 2 more products." PlainRecords, https://plainrecords.com/recall/device/z-1352-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections