# FDA recall Z-1131-2018

> **CooperSurgical, Inc.** · Class II · device recall initiated 2017-10-06.

## Product

Cooper Surgical 2 MHZ Waterproof OB Probe    Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and  department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.

## Reason for recall

The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

## Distribution

Worldwide Distribution - US Nationwide and the countries of ( Canada and England)

## Key facts

- **Recall number:** Z-1131-2018
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-06
- **Report date:** 2018-03-28
- **Termination date:** 2020-02-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Trumbull, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1131-2018

## Citation

> AI Analytics. FDA recall Z-1131-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1131-2018. Source: US FDA. Licensed CC0.

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