Durex Pleasure Pack — Class II medical device recall Z-0994-2019
Terminated recall by Reckitt Benckiser LLC, reported 2019-03-20, distributed nationwide. Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
| Recall number | Z-0994-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reckitt Benckiser LLC, Parsippany, NJ, United States |
| Recall initiated | 2018-12-19 |
| Classified | 2019-03-08 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2021-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AW, BB, GY, HT, JM |
| Quantity | 34,920 |
Product
Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00
Reason for recall
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0994-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.