# FDA recall Z-0523-2018

> **Ecolab, Inc.** · Class II · device recall initiated 2017-10-13.

## Product

Disposable Light Handle Cover, Item Number B1-715-65.  Packaged 1 device inside a peel pouch and sealed.  Sealed pouches are packaged 10 each inside a poly liner.  5 rows of 10 pouches are placed in a labeled corrugated mailer box.     Product Usage:  Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device.

## Reason for recall

Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.

## Distribution

Distributed domestically to Michigan.

## Key facts

- **Recall number:** Z-0523-2018
- **Recalling firm:** Ecolab, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-13
- **Report date:** 2018-02-14
- **Termination date:** 2020-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0523-2018

## Citation

> AI Analytics. FDA recall Z-0523-2018. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0523-2018. Source: US FDA. Licensed CC0.

---

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