# FDA recall Z-1987-2023

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-05-04.

## Product

Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract  Catalog Number: HX-202LR.A

## Reason for recall

Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1987-2023
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-04
- **Report date:** 2023-06-28

- **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-1987-2023

## Citation

> AI Analytics. FDA recall Z-1987-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1987-2023. Source: US FDA. Licensed CC0.

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