HIGH

Olympus Insufflation Unit Recalled Due to Overpressure Hazard

Olympus Corporation recalled 744 High Flow Insufflation Units on January 16, 2026. A software algorithm issue may lead to overpressure events during use. Patients and healthcare providers must stop using the device immediately.

Quick Facts at a Glance

Recall Date
January 16, 2026
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Issue with software algorithm which may lead to overpressure events.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recalled product is the Olympus High Flow Insufflation Unit, Model UHI-2. It was distributed nationwide and sold to healthcare providers and institutions.

The Hazard

The insufflation unit may experience an overpressure event due to a software algorithm issue. This creates a risk of injury to patients during laparoscopic procedures.

Reported Incidents

There have been no reported injuries or deaths associated with this recall. However, the potential for serious injury remains a concern based on the device's intended use.

What to Do

Immediately stop using the Olympus High Flow Insufflation Unit. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions.

Contact Information

For more information, call Olympus Corporation of the Americas at their customer service line or visit their website. More details are available at the FDA's recall page.

Key Facts

  • 744 units recalled
  • Risk of overpressure events
  • Class I recall
  • Immediate stop-use required
  • Nationwide distribution

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Model Number: UHI-2
UDI-DI: N/A
All Serial Numbers
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

Related Recalls

HIGH

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN
cGMP deviations
Read more