# FDA recall Z-0465-2022

> **Technomed Europe** · Class II · device recall initiated 2021-12-08.

## Product

Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

## Reason for recall

There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

## Distribution

US Nationwide distribution in the states of California, Florida, and Ohio.

## Key facts

- **Recall number:** Z-0465-2022
- **Recalling firm:** Technomed Europe
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-08
- **Report date:** 2022-01-19
- **Termination date:** 2024-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maastricht-Airport, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0465-2022

## Citation

> AI Analytics. FDA recall Z-0465-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0465-2022. Source: US FDA. Licensed CC0.

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