# FDA recall Z-2291-2018

> **Exsurco Medical** · Class II · device recall initiated 2018-04-17.

## Product

Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004

## Reason for recall

Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.

## Distribution

CA, GA, MO, OH & TX

## Key facts

- **Recall number:** Z-2291-2018
- **Recalling firm:** Exsurco Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-17
- **Report date:** 2018-07-04
- **Termination date:** 2020-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wakeman, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2291-2018

## Citation

> AI Analytics. FDA recall Z-2291-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2291-2018. Source: US FDA. Licensed CC0.

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