# FDA recall Z-1958-2025

> **Integra LifeSciences Corp. (NeuroSciences)** · Class I · device recall initiated 2025-05-22.

## Product

Extended Tip Applicator, 8CM, Box of 5.

## Reason for recall

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

## Distribution

Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.

## Key facts

- **Recall number:** Z-1958-2025
- **Recalling firm:** Integra LifeSciences Corp. (NeuroSciences)
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-22
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1958-2025

## Citation

> AI Analytics. FDA recall Z-1958-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1958-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*