# FDA recall Z-1418-2023

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-02-23.

## 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 for recall

There have been complaints that the clip did not come out of the tube sheath during the procedure.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1418-2023
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-23
- **Report date:** 2023-04-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1418-2023

## Citation

> AI Analytics. FDA recall Z-1418-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1418-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*