Olympus Corporation of the Americas medical device recall: Brand Name: Single Use Ligating Device Product Name: Olympus…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97731
- Recall initiated
- Oct 30, 2025
- Classified by FDA
- Nov 25, 2025
- Posted in Enforcement Report
- Dec 3, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Firm location
- Center Valley, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Oct 30, 2025. FDA classified it 26 days later, on Nov 25, 2025. Distribution reported by FDA: US-wide distribution Olympus Corporation of the Americas has 145 recalls in our records.
Recalled products (1)
Z-0570-2026 Class I Ongoing
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Codes / lots: Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;
Quantity: 7803 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97731
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.