# FDA recall Z-1844-2021

> **Quanta System, S.p.A.** · Class II · device recall initiated 2021-04-27.

## Product

Quanta System Sterile Optical Laser Fiber, reusable

## Reason for recall

Product sterility is potentially compromised.

## Distribution

Nationwide distribution via 6 US distributors

## Key facts

- **Recall number:** Z-1844-2021
- **Recalling firm:** Quanta System, S.p.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-27
- **Report date:** 2021-06-16
- **Termination date:** 2023-09-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Samarate, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1844-2021

## Citation

> AI Analytics. FDA recall Z-1844-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1844-2021. Source: US FDA. Licensed CC0.

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