# FDA recall Z-1860-2025

> **Pro-Med Instruments Gmbh** · Class II · device recall initiated 2025-03-14.

## Product

DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

## Reason for recall

Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, CO, KY, ID, IL, MA, MO, NC, NJ, NY, TX and the countries of Algeria, Argentina, Australia, Austria, Brazil, Burma, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Mexico, Mongolia, Netherlands, Norway, Philippines, Poland, Qatar, Russia, Russia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom.

## Key facts

- **Recall number:** Z-1860-2025
- **Recalling firm:** Pro-Med Instruments Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-14
- **Report date:** 2025-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Freiburg Im Breisgau, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1860-2025

## Citation

> AI Analytics. FDA recall Z-1860-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1860-2025. Source: US FDA. Licensed CC0.

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