# FDA recall Z-1955-2021

> **Synaptive Medical Inc** · Class II · device recall initiated 2021-04-23.

## Product

Synaptive Trackable Suction Set Standard and Malleable

## Reason for recall

Due to visible burrs/metal filings affixed along the suction tube inner perimeter.

## Distribution

Domestic Distribution: IN, SC, MD, OR, TX ,LA, MI, NY, NV, FL, VA, CA,WI, PA and NC.  International Distribution: Australia, Canada, Belgium, Netherlands, Singapore, Switzerland, Thailand, UK, Vietnam

## Key facts

- **Recall number:** Z-1955-2021
- **Recalling firm:** Synaptive Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-23
- **Report date:** 2021-07-07
- **Termination date:** 2024-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toronto, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1955-2021

## Citation

> AI Analytics. FDA recall Z-1955-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1955-2021. Source: US FDA. Licensed CC0.

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