# FDA recall Z-0780-2022

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

## Product

RX CHOLANGIOGRAM KIT    Material Numbers:   M00575241  M00575281  M00575321  M00575361  M00575381  M00575401  M00575441  M00575481

## 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-0780-2022
- **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-0780-2022

## Citation

> AI Analytics. FDA recall Z-0780-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0780-2022. Source: US FDA. Licensed CC0.

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