# FDA recall Z-1371-2023

> **Coloplast Manufacturing US, LLC** · Class II · device recall initiated 2023-03-01.

## Product

Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis

## Reason for recall

A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

## Distribution

Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.

## Key facts

- **Recall number:** Z-1371-2023
- **Recalling firm:** Coloplast Manufacturing US, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-01
- **Report date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1371-2023

## Citation

> AI Analytics. FDA recall Z-1371-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1371-2023. Source: US FDA. Licensed CC0.

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