# FDA recall Z-0412-2022

> **Leica Microsystems, Inc.** · Class II · device recall initiated 2021-11-03.

## Product

Leica Microsystems M220 F12 Microscope Systems

## Reason for recall

In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, DC, FL, GA, IL, IN, MA, MI, MD, NY, OH, OR, PA, TN, TX, VA, WI, and Puerto Rico. The countries of Albania, Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Canada, Chile, China, Colombia, Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Georgia, Great Britain, Greece, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, South Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal,  North Macedonia, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Uruguay, Vietnam.

## Key facts

- **Recall number:** Z-0412-2022
- **Recalling firm:** Leica Microsystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-03
- **Report date:** 2021-12-29
- **Termination date:** 2024-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Buffalo Grove, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0412-2022

## Citation

> AI Analytics. FDA recall Z-0412-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0412-2022. Source: US FDA. Licensed CC0.

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