# FDA recall Z-0781-2022

> **Boston Scientific Corporation** · Class II · device recall initiated 2021-12-22.

## Product

RX CHOLANGIOGRAM KIT - SINGLE    Material Number:   M00575240  M00575240  M00575280  M00575320  M00575360  M00575380  M00575400  M00575440  M00575480

## Reason for recall

Sterility of device is compromised due to a sterile barrier breach

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,  Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco,  Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland,  Unit. Arab Emir.

## Key facts

- **Recall number:** Z-0781-2022
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-22
- **Report date:** 2022-03-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0781-2022

## Citation

> AI Analytics. FDA recall Z-0781-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0781-2022. Source: US FDA. Licensed CC0.

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