FDA Device recall Z-0570-2026
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to…
- FDA Device
- Class I
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class I recall of Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to… by Olympus, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0570-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-10-30 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | n/a |
Product
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.
Reason
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.
Identifiers
| code_info | Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0570-2026%22
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