# FDA recall Z-2423-2021

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2021-08-03.

## Product

Arc Endocuff Vision as follows: 	 ARV110 ENDOCUFF-V M BLUE PK8,  Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8,  Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8	ARV110,  Part Number: E0420503  Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy

## Reason for recall

Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2423-2021
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-03
- **Report date:** 2021-09-15
- **Termination date:** 2023-01-10

- **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-2423-2021

## Citation

> AI Analytics. FDA recall Z-2423-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2423-2021. Source: US FDA. Licensed CC0.

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