CLASS I ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
Single Use Ligating Device Olympus HX-400U recalled
Olympus Corporation of the Americas is recalling Single Use Ligating Device Olympus HX-400U-30. The recall was initiated on 30 Oct 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0570-2026
- FDA event ID
- 97731
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 30 Oct 2025
- FDA classified
- 25 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 30 Oct 2025 | Recall initiated by company | |
| 25 Nov 2025 | Classified by FDA | +26 days |
| 3 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US-wide distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;
Where was it sold?
US-wide distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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