# FDA recall Z-1539-2018

> **Beaver-Visitec International Inc.** · Class II · device recall initiated 2018-02-26.

## Product

WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270.    Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.

## Reason for recall

Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.

## Distribution

Distributed to the states of OH, NY, FL, MN, and KS.

## Key facts

- **Recall number:** Z-1539-2018
- **Recalling firm:** Beaver-Visitec International Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-26
- **Report date:** 2018-05-09
- **Termination date:** 2019-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1539-2018

## Citation

> AI Analytics. FDA recall Z-1539-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1539-2018. Source: US FDA. Licensed CC0.

---

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