# FDA recall Z-0091-2019

> **Reckitt Benckiser LLC** · Class II · device recall initiated 2018-08-06.

## Product

Polyisoprene condomns    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

Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life

## Distribution

US in the states of NY

## Key facts

- **Recall number:** Z-0091-2019
- **Recalling firm:** Reckitt Benckiser LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-06
- **Report date:** 2018-10-17
- **Termination date:** 2019-11-12

- **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-0091-2019

## Citation

> AI Analytics. FDA recall Z-0091-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0091-2019. Source: US FDA. Licensed CC0.

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