# FDA recall Z-3241-2018

> **Reckitt Benckiser LLC** · Class II · device recall initiated 2018-07-23.

## Product

Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00    Product Usage:  The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

## Reason for recall

The products failed the filed specification of 1.0kPa for Burst Pressure.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-3241-2018
- **Recalling firm:** Reckitt Benckiser LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-23
- **Report date:** 2018-10-03
- **Termination date:** 2020-03-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3241-2018

## Citation

> AI Analytics. FDA recall Z-3241-2018. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-3241-2018. Source: US FDA. Licensed CC0.

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