FDA Device recall Z-1418-2023
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - R…
- FDA Device
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - R… by Olympus, citing there have been complaints that the clip did not come out of the tube sheath during the procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1418-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-23 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
Reason
There have been complaints that the clip did not come out of the tube sheath during the procedure.
Identifiers
| code_info | 1) UDI-DI 14953170353106; Model HX-201LR-135; Lot 1ZV 2) UDI-DI 14953170353113; Model HX-201UR-135; Lot 23V 3) UDI-DI…1) UDI-DI 14953170353106; Model HX-201LR-135; Lot 1ZV 2) UDI-DI 14953170353113; Model HX-201UR-135; Lot 23V 3) UDI-DI 14953170353120; Model HX-201UR-135; Lot 24V 4) UDI-DI 14953170353168; Model HX-201UR-135L; Lot 24V |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1418-2023%22
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