# FDA recall Z-1516-2025

> **Ethicon Endo Surgery,  LLC** · Class II · device recall initiated 2025-03-07.

## Product

ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH

## Reason for recall

Identified curing issues with the silicone during the needles manufacturing process.

## Distribution

Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.

## Key facts

- **Recall number:** Z-1516-2025
- **Recalling firm:** Ethicon Endo Surgery,  LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-07
- **Report date:** 2025-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Guaynabo, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1516-2025

## Citation

> AI Analytics. FDA recall Z-1516-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1516-2025. Source: US FDA. Licensed CC0.

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