# FDA recall Z-1114-2025

> **US Endodontics, LLC** · Class II · device recall initiated 2025-01-02.

## Product

Brasseler ESR Rotary/Reciprocating Endodontic File   Device SKU  AP120213PK  AP120253PK  AP120313PK  AP125213PK  AP125253PK  AP125313PK  AP135213PK  AP135253PK  AP135313PK  AP145213PK  AP145253PK  AP145313PK  AP1GP213PK  AP1GP253PK  AP1GP313PK    O.U.S. Products:  EdgeFile X7 REF:  SX70421MM  SX70425MM  SX70429MM  SX70621MM  SX70625MM  SX70629MM  SX7170421RF  SX7170425RF  SX7170429RF  SX7170621RF  SX7170625RF  SX7170629RF  SX7200421RF  SX7200425RF  SX7200429RF  SX7200621RF  SX7200625RF  SX7200629RF  SX7250421RF  SX7250425RF  SX7250429RF  SX7250621RF  SX7250625RF  SX7250629RF  SX7300421RF  SX7300425RF  SX7300429RF  SX7300621RF  SX7300625RF  SX7300629RF  SX7350421RF  SX7350425RF  SX7350429RF  SX7350621RF  SX7350625RF  SX7350629RF  SX7400421RF  SX7400425RF  SX7400429RF  SX7400621RF  SX7400625RF  SX7400629RF  SX7450421RF  SX7450425RF  SX7450429RF  SX7450621RF  SX7450625RF  SX7450629RF    EdgeGlidePath REF:  SEGP0221  SEGP0225  SEGP0231    EdgeOne Fire REF:  SEOFAST21  SEOFAST25  SEOFAST31 

## Reason for recall

Due to devices being irradiated above the established specification which my result in package integrity issues.

## Distribution

Worldwide - US Nationwide distribution in the state of GA and the countries of Australia, Canada, the European Union (specifically France, Germany, Italy, Poland, and Spain), and the UK.

## Key facts

- **Recall number:** Z-1114-2025
- **Recalling firm:** US Endodontics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-02
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Johnson City, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1114-2025

## Citation

> AI Analytics. FDA recall Z-1114-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1114-2025. Source: US FDA. Licensed CC0.

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